A closely watched medicine made from the marijuana plant reduces seizures in children with severe forms of epilepsy and warrants approval in the United States, health officials said Tuesday.
FILE - This May 23, 2017, file photo shows GW Pharmaceuticals’ Epidiolex, a medicine made from the marijuana plant but without TCH. (AP Photo/Kathy Young, File)
British drugmaker GW Pharmaceuticals is seeking permission to sell its purified form of an ingredient found in cannabis — one that doesn't get users high — as a medication for rare, hard-to-treat seizures in children. If successful, the company's liquid formula would be the first government-approved drug derived from the cannabis plant in the U.S.
The Food and Drug Administration's approval would technically limit the treatment to a small group of epilepsy patients. But doctors would have the option to prescribe it for other uses and it could spur new pharmaceutical research and interest into other cannabis-based products. Man-made versions of a different marijuana ingredient have previously been approved for other purposes.
The FDA posted its review of the experimental medication Epidiolex ahead of a public meeting Thursday when a panel of outside experts will vote on the medicine's safety and effectiveness. It's a non-binding recommendation that the FDA will consider in its final decision by late June.
Patients taking the treatment had fewer seizures, according to the FDA's internal review posted online. Scientists concluded that GW Pharmaceutical's submission "appears to support approval" despite some potential side effects including risks of liver injury.
FILE - In this Feb. 14, 2018, file photo, marijuana plants are displayed at a dispensary in Berkeley, Calif. U.S. health officials say a closely watched medicine made from the marijuana plant significantly reduces seizures in children with severe forms of epilepsy and warrants approval in the U.S. (AP Photo/Marcio Jose Sanchez, File)
More than two dozen states allow marijuana use for a variety of ailments, but the FDA has not approved it for any medical use. In 2016, the agency recommended against easing federal restrictions on marijuana. The U.S. continues to classify marijuana as a high-risk substance with no medical use, alongside other illicit drugs like heroin and LSD.
For years, desperate patients and parents have pushed for wider access to medical marijuana products for a host of conditions including pain, post-traumatic stress disorder and epilepsy, with only anecdotal stories and limited studies on their side.
But studies conducted by GW Pharmaceuticals have begun to change that picture.
Across three studies involving more than 500 patients, Epidiolex generally cut the number of monthly seizures by about 40 percent, compared with reductions between 15 and 20 percent for patients taking a dummy medicine.
Most patients in the study were already taking at least three other medications to try and control their seizures.
Epidiolex is essentially a pharmaceutical-grade version of cannabidiol, or CBD oil, which some parents have used for years to treat children with epilepsy. CBD is one of more than 100 chemicals found in the cannabis plant and it doesn't contain THC, the ingredient that gives marijuana its mind-altering effect.
CBD oil is currently sold online and in specialty shops across the U.S., though its legal status remains murky. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.
GW Pharmaceuticals declined to comment on the price of the drug ahead of an approval decision. Wall Street analysts estimate it could cost more than $25,000 per year, with annual sales eventually reaching $1 billion.
A doctor who treats children with epilepsy says it's important to have an FDA-approved version of CBD.
"I think it needs to be approved because everyone is using it across the internet without knowing the safety ... and no one is watching the interactions with other drugs," said Dr. Joan Conry of Children's National Health System in Washington, who was not involved in the studies.
Conry and other researchers say it's not yet clear why CBD reduces seizures in some patients.
GW Pharmaceuticals makes its drug from cannabis plants that are specially bred to contain high levels of CBD. It's seeking approval for two rare forms of childhood epilepsy — Dravet and Lennox-Gastaut syndromes.
Common side effects included diarrhea, vomiting, fatigue and sleep problems. FDA reviewers flagged a more serious issue with potential liver injury, but said doctors could manage the risk by monitoring patients' enzyme levels.
KYIV, Ukraine (AP) — U.S. Secretary of State Antony Blinken said Tuesday that American military aid on its way to Ukraine will make a “real difference” on the battlefield, as the top diplomat made an unannounced visit to reassure an ally facing a fierce new Russian offensive.
In increasingly intense attacks along the northeastern border in recent days, Moscow’s troops have captured around 100 to 125 square kilometers (about 40 to 50 square miles) of territory that includes at least seven villages, according to open source monitoring analysts. Though most of those villages were already depopulated, thousands of civilians in the area have fled the fighting.
Analysts have called this moment one of the most dangerous for Ukraine since Russia's full-scale invasion in February 2022 — and President Volodymyr Zelenskyy asked Tuesday for more air defense systems to protect civilians under Russian fire in the northeast.
“We know this is a challenging time,” Blinken said in the Ukrainian capital where he met with Zelenskyy. But he added that American military aid is “going to make a real difference against the ongoing Russian aggression on the battlefield.”
The visit comes less than a month after Congress approved a long-delayed foreign assistance package that sets aside $60 billion in aid for Ukraine, much of which will go toward replenishing badly depleted artillery and air defense systems.
Some of that “is now on the way,” Blinken said, and some has already arrived in Ukraine.
Moscow’s renewed offensive in the northeastern region of Kharkiv is the most significant border incursion since the early days of the war — and comes after months when the roughly 1,000-kilometer (620-mile) front line barely budged.
More than 7,500 civilians have been evacuated from the area, according to authorities. The Kremlin’s forces are also expanding their push to the northern border regions of Sumy and Chernihiv, Ukrainian officials say, and Kyiv's outgunned and outnumbered soldiers are struggling to hold them back.
Troops fought street to street on the outskirts of Vovchansk, which is among the largest towns in the Kharkiv area, regional Gov. Oleh Syniehubov said on national television. Two civilians were killed in Russian shelling Tuesday, he said.
The U.N. human rights office said the battles are taking a heavy toll.
“We are deeply concerned at the plight of civilians in Ukraine,” Liz Throssell, spokeswoman for the office of the U.N. High Commissioner for Human Rights, said in Geneva. “In the Kharkiv region, the situation is dire.”
Zelenskyy thanked Blinken for the U.S. aid — but added that more is necessary, including two Patriot air defense systems that are urgently needed to protect Kharkiv.
“The people are under attack: civilians, warriors, everybody. They’re under Russian missiles,” he said.
Artillery, air defense interceptors and long-range ballistic missiles have already been delivered, some of them already to the front lines, said a senior U.S. official traveling with the secretary on an overnight train from Poland who spoke to reporters on condition of anonymity ahead of Blinken’s meetings.
Ahead of the trip, U.S. officials noted that since President Joe Biden signed the aid package late last month, the administration has already announced $1.4 billion in short-term military assistance and $6 billion in longer-term support.
The administration is “trying to really accelerate the tempo” of U.S. weapon shipments, said national security adviser Jake Sullivan.
But delays in U.S. assistance, particularly since the Israel-Hamas war began and has preoccupied top administration officials, have triggered deep concerns in Kyiv and Europe. Blinken, for example, has visited the Middle East seven times since the Gaza conflict began in October. His last trip to Kyiv was in September.
On his fourth trip to Kyiv since Russian troops rolled over the border, Blinken emphasized the United States' support for Ukraine's independence and eventual recovery, according to spokesperson Matthew Miller. The U.S. diplomat and the Ukrainian president also discussed long-term security arrangements and Ukraine's economic welfare.
Blinken was due to give a speech later Tuesday extolling Ukraine’s “strategic successes” in the war. It is intended to complement a Blinken address last year in Helsinki, Finland, deriding Putin for Moscow’s strategic failures in launching the war.
Since the Helsinki speech, however, Russia has intensified its attacks, most noticeably as the U.S. House of Representatives sat on the aid package for months without action, forcing a suspension in the provision of most U.S. assistance. Those attacks have increased in recent weeks as Russia has sought to take advantage of Ukrainian shortages in manpower and weapons while the new assistance is in transit.
Meanwhile, Russian President Vladimir Putin plans to make a two-day state visit to China this week, the Chinese Foreign Ministry said. Beijing has backed Moscow politically in the war and has sent machine tools, electronics and other items seen as contributing to the Russian war effort, without actually exporting weaponry.
“A strong, successful, thriving, free Ukraine is the best possible rebuke to Putin and the best possible guarantor for your future,” Blinken told Zelenskyy in Kyiv.
The senior U.S. official said despite some recent setbacks, Ukraine could still claim significant victories. Those include reclaiming some 50% of the territory Russian forces took in the early months of the war, boosting its economic standing and improving transportation and trade links, not least through military successes in the Black Sea.
The official acknowledged that Ukraine faces “a tough fight” and is “under tremendous pressure” but argued that Ukrainians “will become increasingly more confident” as the new U.S. and other Western assistance begins to arrive.
Associated Press writers Aamer Madhani in Washington, Illia Novikov in Kyiv, Ukraine, and Jamey Keaten in Geneva contributed to this report.
Follow AP’s coverage of the war in Ukraine at https://apnews.com/hub/russia-ukraine
In this photo provided by the Ukrainian Presidential Press Office, Ukraine's President Volodymyr Zelenskyy, fourth left, speaks during a meeting with U.S. Secretary of State Antony Blinken, third right, in Kyiv, Ukraine, Tuesday, May 14, 2024. Blinken arrived in Kyiv on Tuesday in an unannounced diplomatic mission to reassure Ukraine that it has American support as it struggles to defend against increasingly intense Russian attacks. (Ukrainian Presidential Press Office via AP)
U.S. Secretary of State Antony Blinken, center, attends a meeting with Ukraine's President Volodymyr Zelenskyy in Kyiv, Ukraine, Tuesday, May 14, 2024. Blinken arrived in Kyiv on Tuesday in an unannounced diplomatic mission to reassure Ukraine that it has American support as it struggles to defend against increasingly intense Russian attacks. (Brendan Smialowski/Pool Photo via AP)
In this photo provided by the Ukrainian Presidential Press Office, Ukraine's President Volodymyr Zelenskyy speaks during a meeting with U.S. Secretary of State Antony Blinken in Kyiv, Ukraine, Tuesday, May 14, 2024. Blinken arrived in Kyiv on Tuesday in an unannounced diplomatic mission to reassure Ukraine that it has American support as it struggles to defend against increasingly intense Russian attacks. (Ukrainian Presidential Press Office via AP)
In this photo provided by the Ukrainian Presidential Press Office, Ukraine's President Volodymyr Zelenskyy, left, greets U.S. Secretary of State Antony Blinken, right, prior to their meeting in Kyiv, Ukraine, Tuesday, May 14, 2024. Blinken arrived in Kyiv on Tuesday in an unannounced diplomatic mission to reassure Ukraine that it has American support as it struggles to defend against increasingly intense Russian attacks. (Ukrainian Presidential Press Office via AP)
In this photo provided by the Ukrainian Presidential Press Office, Ukraine's President Volodymyr Zelenskyy speaks during a meeting with U.S. Secretary of State Antony Blinken in Kyiv, Ukraine, Tuesday, May 14, 2024. Blinken arrived in Kyiv on Tuesday in an unannounced diplomatic mission to reassure Ukraine that it has American support as it struggles to defend against increasingly intense Russian attacks. (Ukrainian Presidential Press Office via AP)
In this photo provided by the Ukrainian Presidential Press Office, U.S. Secretary of State Antony Blinken attends a meeting with Ukraine's President Volodymyr Zelenskyy in Kyiv, Ukraine, Tuesday, May 14, 2024. Blinken arrived in Kyiv on Tuesday in an unannounced diplomatic mission to reassure Ukraine that it has American support as it struggles to defend against increasingly intense Russian attacks. (Ukrainian Presidential Press Office via AP)
In this photo provided by the Ukrainian Presidential Press Office, Ukraine's President Volodymyr Zelenskyy, left, greets U.S. Secretary of State Antony Blinken, right, prior to their meeting in Kyiv, Ukraine, Tuesday, May 14, 2024. Blinken arrived in Kyiv on Tuesday in an unannounced diplomatic mission to reassure Ukraine that it has American support as it struggles to defend against increasingly intense Russian attacks. (Ukrainian Presidential Press Office via AP)
U.S. Secretary of State Antony Blinken, center, watches Ukraine's President Volodymyr Zelenskyy, left, greets U.S. Ambassador to Ukraine Bridget Brink, right, prior to their meeting in Kyiv Tuesday, May 14, 2024. Blinken arrived in Kyiv on Tuesday in an unannounced diplomatic mission to reassure Ukraine that it has American support as it struggles to defend against increasingly intense Russian attacks. (Brendan Smialowski/Pool Photo via AP)
Ukraine's President Volodymyr Zelenskyy, left, greets U.S. Secretary of State Antony Blinken, right, prior to their meeting in Kyiv, Ukraine, Tuesday, May 14, 2024. Blinken arrived in Kyiv on Tuesday in an unannounced diplomatic mission to reassure Ukraine that it has American support as it struggles to defend against increasingly intense Russian attacks. (Brendan Smialowski/Pool Photo via AP)
U.S. Secretary of State Antony Blinken, right, arrives by train at Kyiv-Pasazhyrskyi station Tuesday, May 14, 2024, in Kyiv, Ukraine. (Brendan Smialowski/Pool Photo via AP)
U.S. Secretary of State Antony Blinken works while traveling on a Ukraine Railways train to Kiev, Monday, May 13, 2024, near Lviv, Ukraine. (Brendan Smialowski/Pool Photo via AP)
U.S. Ambassador to Ukraine Bridget Brink, front, waits with Ukrainian Railways staff and others to greet U.S. Secretary of State Antony Blinken at Kyiv-Pasazhyrskyi station Tuesday, May 14, 2024, in Kyiv, Ukraine. (Photo by Brendan Smialowski/Pool Photo via AP)
U.S. Secretary of State Antony Blinken, right, arrives by train at Kyiv-Pasazhyrskyi station Tuesday, May 14, 2024, in Kyiv, Ukraine. (Brendan Smialowski/Pool Photo via AP)
U.S. Secretary of State Antony Blinken works while traveling on a Ukraine Railways train to Kiev, Monday, May 13, 2024, near Lviv, Ukraine. (Brendan Smialowski/Pool Photo via AP)
U.S. Secretary of State Antony Blinken, center, walks to board a Ukrainian Railways train at Przemysl Glowny train station while traveling to Kyiv, Ukraine, Monday, May 13, 2024, from Przemysl, Poland. (Brendan Smialowski/Pool Photo via AP)
U.S. Secretary of State Antony Blinken is greeted by U.S. Ambassador to Ukraine Bridget A. Brink after arriving by train at Kyiv-Pasazhyrskyi station May 14, 2024, in Kyiv, Ukraine. (Brendan Smialowski(Photographers name/Pool Photo via AP)
Secretary of State Antony Blinken speaks at the RSA Conference in San Francisco, Monday, May 6, 2024. (AP Photo/Jeff Chiu)
U.S. Secretary of State Antony Blinken works while traveling on a Ukraine Railways train to Kiev, Monday, May 13, 2024, near Lviv, Ukraine. (Brendan Smialowski/Pool Photo via AP)
