WASHINGTON (AP) — The maker of a drug for Lou Gehrig’s disease that recently failed in a large study said Thursday it will pull the medicine from the market, acknowledging it didn't help patients with the deadly neurological condition.
Amylyx Pharmaceuticals announced it will voluntarily halt sales and marketing of the drug in the U.S. and Canada, where new patients will no longer be able to get a prescription.
“While this is a difficult moment for the ALS community, we reached this path forward in partnership with the stakeholders who will be impacted and in line with our steadfast commitment to people living with ALS," company co-founders said in a statement. Patients already taking the therapy who wish to continue will be able to enroll in a program to receive it for free.
The Food and Drug Administration approved the much-debated drug, Relyvrio, in September 2022, following a years-long advocacy campaign by patients with amyotrophic lateral sclerosis, or ALS.
The drug's failure is a bitter disappointment for patients and advocates, who have pressed the FDA and other federal agencies to fund and approve more experimental therapies for the fatal muscle-wasting disease.
Relyvrio's withdrawal leaves just three ALS medicines available to U.S. patients, only one of which has been shown to extend survival by several months.
Cambridge, Massachusetts-based Amylyx also said Thursday it will lay off 70% of its more than 350 employees as part of a major restructuring effort. Company executives said they plan to continue studying Relyvrio and another experimental drug for several rare diseases, including Wolfram syndrome, which causes childhood diabetes and blindness.
Company shares climbed more than 7.5% in trading Thursday morning.
Amylyx said last month it was considering pulling its drug after a clinical trial in 600 patients failed to show any improvements in survival or other health measures, such as muscle strength or walking ability.
The company's voluntary action resolves what could have been a major dilemma for the FDA. The agency's regulators would not have had a clear path to quickly force the drug from the market if the company had refused to remove it. That's because the FDA granted the drug full approval, despite the preliminary nature of the company's data on effectiveness.
The 2022 approval was mainly based on results from one small, mid-stage study that was criticized by some of the agency’s own internal scientists. Normally the agency requires two large, late-stage studies that show a clear benefit before granting approval. But at the time FDA officials explained that “regulatory flexibility” was appropriate when reviewing Relyvrio, “given the serious and life-threatening nature of ALS and the substantial unmet need.”
The medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable evidence they work.
ALS gradually destroys the nerve cells and connections needed to walk, talk, speak and breathe. Most patients die within three to five years of a diagnosis.
Relyvrio is a powder that combines two older drugs: a prescription medication for liver disorders and a dietary supplement associated with traditional Chinese medicine.
Amylyx faced criticism for pricing the drug at $158,000 for a year’s supply. Sales were disappointing, with some patients discontinuing the medicine after only a few months.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
FILE - This image provided by Amylyx Pharmaceuticals shows the drug Relyvrio. The maker of a drug for Lou Gehrig’s disease that recently failed in a large study said Thursday, April 4, 2024 it will pull the medicine from the U.S. market, acknowledging it didn't help patients with the deadly neurological condition. (Amylyx Pharmaceuticals via AP)
Israel's military has ordered tens of thousands of people in the southern Gaza city of Rafah to begin evacuating, signaling that a long-promised ground invasion could be imminent.
The announcement on Monday complicated last-ditch efforts by international mediators to broker a cease-fire. Hamas and Qatar, a key mediator, have warned that an invasion of Rafah could derail the talks.
Israel has described Rafah as the last significant Hamas stronghold after seven months of war, and its leaders have repeatedly said they need to carry out a ground invasion to defeat the Islamic militant group.
Lt. Col. Nadav Shoshani, an army spokesman, said some 100,000 people were being ordered to move to a nearby Israel-declared humanitarian zone called Muwasi. He said Israel was preparing a “limited scope operation” and would not say whether this was the beginning of a broader invasion of the city.
The Israel-Hamas war has driven around 80% of Gaza’s population of 2.3 million from their homes and caused vast destruction in several towns and cities. The death toll in Gaza has soared to more than 34,500 people, according to local health officials.
The war began Oct. 7 when Hamas attacked southern Israel, abducting about 250 people and killing around 1,200, mostly civilians. Israel says militants still hold around 100 hostages and the remains of more than 30 others.
Currently:
— Israeli army tells Palestinians to evacuate parts of Rafah ahead of an expected assault
— Hamas says latest cease-fire talks have ended. Israel vows military operation in ‘very near future’
— Israel orders Al Jazeera to close its local operation and seizes some of its equipment
— Netanyahu uses Holocaust ceremony to brush off international pressure against Gaza offensive
— Anti-war protesters leave USC after police arrive, while Northeastern ceremony proceeds calmly
— Israeli strike kills 4 civilians in southern Lebanon, state media says
Follow AP’s coverage of the war at https://apnews.com/hub/israel-hamas-war
Here's the latest:
JERUSALEM — The Israeli army has ordered tens of thousands of people in the southern Gaza city of Rafah to begin evacuating, signaling that a long-promised ground invasion could be imminent.
The announcement on Monday complicated last-ditch efforts by international mediators, including the director of the CIA, to broker a cease-fire. Hamas and Qatar, a key mediator, have warned that an invasion of Rafah could derail the talks.
Israel has described Rafah as the last significant Hamas stronghold after seven months of war, and its leaders have repeatedly said they need to carry out a ground invasion to defeat the Islamic militant group.
Lt. Col. Nadav Shoshani, an army spokesman, said some 100,000 people were being ordered to move to a nearby Israel-declared humanitarian zone called Muwasi. He said Israel was preparing a “limited scope operation” and would not say whether this was the beginning of a broader invasion of the city. But last October, Israel did not formally announce the launch of a ground invasion that continues to this day.
BEIRUT — An Israeli airstrike on northeastern Lebanon wounded three people and destroyed a building, Lebanon’s state-run National News Agency says.
The strike on the village of Safri early Monday targeted a factory in the eastern Bekaa Valley, the agency said without giving further details.
The Israeli military said its fighter jets struck a Hezbollah military structure in Safri.
Monday’s strike came after a tense day along the Lebanon-Israel border during which an Israeli airstrike on a village near the border killed four Lebanese civilians.
The militant Hezbollah group said it fired dozens of rockets in retaliation toward northern Israel.
The Lebanon-Israel border has seen almost daily exchange of fire since a day after the Israel-Hamas war started on Oct. 7.
Israeli strikes have killed more than 350 people in Lebanon, most of them fighters with Hezbollah and allied groups but also including more than 50 civilians. In Israel, strikes from Lebanon have killed at least 10 civilians and 12 soldiers.
The office of late Al Jazeera network journalist Shireen Abu Akleh is decorated with memorial items, inside the network's office, in the West Bank city of Ramallah Sunday, May 5, 2024. Israel ordered the local offices of Qatar's Al Jazeera satellite news network to close Sunday, escalating a long-running feud between the broadcaster and Prime Minister Benjamin Netanyahu's hard-line government as Doha-mediated cease-fire negotiations with Hamas hang in the balance. (AP Photo/Nasser Nasser)
Palestinians react next to the bodies of their relatives who were killed in an Israeli airstrike in Gaza Stirp, at the Al Aqsa hospital in Deir al Balah, Gaza, Sunday, May 5, 2024. (AP Photo/Abdel Kareem Hana)
Palestinians react next to the bodies of their relatives who were killed in an Israeli airstrike in Gaza Stirp, at the Al Aqsa hospital in Deir al Balah, Gaza, Sunday, May 5, 2024. (AP Photo/Abdel Kareem Hana)
A Palestinian woman mourns her relative, 7-month old baby Hani Qeshta, who was killed in an Israeli bombardment on a residential building with Qeshta's family, at the morgue of Al Najjar hospital in Rafah, southern Gaza Strip, Sunday, May 5, 2024. (AP Photo/Ismael Abu Dayyah)
Israeli soldiers drive a tank at a staging ground near the border with the Gaza Strip, in southern Israel, Sunday, May 5, 2024. (AP Photo/Tsafrir Abayov)
The Qeshta family is seen in body bags at the morgue of Al Najjar hospital in Rafah, southern Gaza Strip, Sunday, May 5, 2024. The family was killed in an Israeli bombardment on a residential building in Rafah. (AP Photo/Ismael Abu Dayyah)
