European regulators have finally approved the Alzheimer’s treatment Leqembi after an advisory committee initially rejected the drug last summer and then reconsidered it.
The infused treatment from Japanese drugmaker Eisai and Biogen received approval for patients in early stages of the fatal, mind-robbing disease. The decision applies to all 27 members of the European Union plus Norway, Iceland and Liechtenstein, the drugmakers said late Tuesday.
The European Committee for Medicinal Products for Human Use initially said last July that the drug should not receive marketing approval due to concerns about its side effects. Those include brain bleeding and swelling, which can be dangerous in rare cases.
Eisai asked the committee to reconsider its decision, and it then recommended approval in November.
Leqembi clears a sticky brain plaque linked to the disease. A large study has shown that it slowed memory and thinking decline by several months in those who received the treatment compared to those who got a dummy drug.
The drug was approved in Europe for patients with the brain plaque and one or no copies of a certain gene, making them less likely to experience side effects.
The European approval confirms Leqembi's positive risk-benefit profile, TD Cowen analyst Phil Nadeau said in a research note. But he added that the drug's European debut will likely be slow, developing over several years.
Eisai developed Leqembi and is co-marketing it with Cambridge, Massachusetts-based Biogen Inc.
The drug and a competing treatment, Kisunla, from Eli Lilly and Co. are the first to convincingly show a delay in cognitive decline for patients. Both have both been approved by U.S. regulators.
But the European committee said last month that Kisunla shouldn’t receive approval due to side effect concerns. Indianapolis-based Lilly said it hopes to continue discussing the drug through a decision reexamination.
Biogen shares rose about 25 cents to $117.23 in midday trading Wednesday while broader indexes slipped.
FILE - The Biogen Inc., headquarters is pictured on March 11, 2020, in Cambridge, Mass. (AP Photo/Steven Senne, File)
WASHINGTON (AP) — Diane Crump, who in 1969 became the first woman to ride professionally in a horse race and a year later became the first female jockey in the Kentucky Derby, has died. She was 77.
Crump was diagnosed in October with an aggressive form of brain cancer and died Thursday night in hospice care in Winchester, Virginia, her daughter, Della Payne, told The Associated Press.
Crump went on to win 228 races before riding her last race in 1998, a month shy of her 50th birthday and nearly 30 years after her trailblazing ride at Hialeah Park in Florida on Feb. 7, 1969.
Crump was among several women to fight successfully at the time to be granted a jockey license, but they still needed a trainer willing to put them in a race and then for the race to run. Others were thwarted when male jockeys boycotted or threatened to boycott if a woman was riding.
Photographs of Crump's walk to the saddling area at Hialeah show her protected by security guards as a crowd pressed in on all sides. Six of the original 12 jockeys in the race had refused to ride, Mark Shrager wrote in his biography, “Diane Crump: A Horse Racing Pioneer’s Life in the Saddle.” Among them were future legends Angel Cordero Jr., Jorge Velasquez and Ron Turcotte, who four years later would ride Secretariat to win the Triple Crown.
But other jockeys stepped up, and as the 12 horses made their way onto the track, the bugler skipped the traditional call to the post and instead played “Smile for Me, My Diane.” Crump, on a 50-1 longshot called Bridle ’n Bit, finished 10th, but the barrier had been broken. A month later, Bridle ’n Bit gave Crump her first victory at Gulfstream Park.
She again made history in 1970 by becoming the first woman to ride in the Kentucky Derby. She won the first race that day at Churchill Downs, but again her mount for the history-making race was outclassed. She finished 15th out of 17 on Fathom.
It would be 14 more years before another female jockey would ride in the Derby, with only four more to follow in the decades since.
The racetrack president at Churchill Downs, Mike Anderson, said in a statement on Friday that Crump “will be forever respected and fondly remembered in horse racing lore.”
He noted that Crump, who had been riding since age 5 and galloping young Thoroughbreds since she was a teenager, “was an iconic trailblazer who admirably fulfilled her childhood dreams.”
Chris Goodlett, of the Kentucky Derby Museum, said “Diane Crump's name stands for courage, grit, and progress.” He added: “Her determination in the face of overwhelming odds opened doors for generations of female jockeys and inspired countless others far beyond racing.”
After retiring from racing, Crump settled in Virginia and started a business helping people buy and sell horses.
In later years, she took her therapy dogs, all Dachshunds, to visit patients in hospitals and other medical clinics. Some with chronic illnesses she visited regularly for years.
Payne said when her mother went into hospice in November, she was already “quasi-famous” in the medical center because of how much time she had spent there, and a “steady stream” of doctors and nurses came to see her. One of the last people to visit her was the man who mowed her lawn.
Her daughter said Crump would never take “no” for an answer, whether it was becoming a jockey or helping someone in need.
“I wouldn’t say she was as competitive as she was stubborn,” Payne said. “If someone was counting on her, she could never let someone down.”
Late in life, Crump's mottos were literally tattooed on her forearms: “Kindness” on the left, “Compassion” on the right.
Crump will be cremated and her ashes interred between her parents in Prospect Hill Cemetery in Front Royal, Virginia.
FILE - In this undated 1970 photo, jockey Diane Crump, 21, poses for a photo with Fathom in Louisville, Kentucky. Crump, who in 1969 became the first woman to ride professionally in a horse race and a year later became the first female jockey in the Kentucky Derby, died Thursday, Jan. 1, 2026. She was 77. (AP Photo, File)
FILE - Diane Crump, apprentice jockey, kisses her mount Tou Ritzi, after winning a Churchill Downs race in Louisville, Kentucky, April 29, 1969. Crump, who in 1969 became the first woman to ride professionally in a horse race and a year later became the first female jockey in the Kentucky Derby, died Thursday, Jan. 1, 2026. She was 77. (AP Photo/Gene Herrick, File)
FILE - Jockey Diane Crump sports a mud pack on her cap and face after winning a Kentucky Derby race riding Right Sean, in Louisville, Kentucky, May 2, 1970. Crump, who in 1969 became the first woman to ride professionally in a horse race and a year later became the first female jockey in the Kentucky Derby, died Thursday, Jan. 1, 2026. She was 77. (AP Photo, File)
