Day: June 10, 2024

Alzheimer’s drug that slows disease gets backing from FDA advisers

WASHINGTON — A closely watched Alzheimer’s drug from Eli Lilly won the backing of federal health advisers Monday, setting the stage for the treatment’s expected approval for people with mild dementia caused by the brain-robbing disease. 

Food and Drug Administration advisers voted unanimously that the drug’s ability to slow the disease outweighs its risks, including side effects like brain swelling and bleeding that will have to be monitored. 

“I thought the evidence was very strong in the trial showing the effectiveness of the drug,” said panel member Dean Follmann, a National Institutes of Health statistician. 

The FDA will make the final decision on approval later this year. If the agency agrees with the panel’s recommendation, the drug, donanemab, would only be the second Alzheimer’s drug cleared in the U.S. that’s been shown to convincingly slow cognitive decline and memory problems due to Alzheimer’s. The FDA approved a similar infused drug, Leqembi, from Japanese drugmaker Eisai last year. 

The slowdown seen with both drugs amounts to several months and experts disagree on whether patients or their loved ones will be able to detect the difference. 

But Lilly’s approach to studying its once-a-month treatment prompted questions from FDA reviewers. 

Patients in the company’s study were grouped based on their levels of a brain protein,  

called tau, that predicts severity of cognitive problems. That led the FDA to question whether patients might need to be screened via brain scans for tau before getting the drug. But most panelists thought there was enough evidence of the drug’s benefit to prescribe it broadly, without screening for the protein. 

“Imposing a requirement for tau imaging is not necessary and would raise serious practical and access concerns to the treatment,” said Dr. Thomas Montine of Stanford University, who chaired the panel and summarized its opinion. 

At a high level, Lilly’s results mirrored those of Leqembi, with both medications showing a modest slowing of cognitive problems in patients with early-stage Alzheimer’s. The Indianapolis-based company conducted a 1,700-patient study showing patients who received monthly IV infusions of its drug declined about 35% more slowly than those who got a placebo treatment. 

The FDA had been widely expected to approve the drug in March. But instead, the agency said it would ask its panel of neurology experts to publicly review the company’s data, an unexpected delay that surprised analysts and investors. 

Several unusual approaches in how Lilly tested its drug led to the meeting. 

One change was measuring patients’ tau — and excluding patients with very low or no levels of the protein. But panelists said there was enough data from other measures to feel confident that nearly all patients could benefit from the drug, regardless of their levels. 

In another key difference, Lilly studied taking patients off its drug when they reached very low levels of amyloid, a sticky brain plaque that’s a contributor to Alzheimer’s. 

Lilly scientists suggested stopping treatment is a key advantage for its drug, which could reduce side effects and costs. But FDA staff said Lilly provided little data supporting the optimal time to stop or how quickly patients might need to restart treatment. 

Despite those questions, many panelists thought the possibility of stopping doses held promise. 

“It’s a huge cost savings for the society, we’re talking about expensive treatment, expensive surveillance,” said Dr. Tanya Simuni of Northwestern University. She and other experts said patients would need to be tracked and tested to see how they fare and whether they need to resume treatment. 

The main safety issue with donanemab was brain swelling and bleeding, a problem common to all amyloid-targeting drugs. Most cases identified in Lilly’s trial were mild. 

Three deaths in the donanemab study were linked to the drug, according to the FDA, all involving brain swelling or bleeding. One of the deaths was caused by a stroke, a life-threatening complication that occurs more frequently among Alzheimer’s patients. 

The FDA’s panel agreed those risks could be addressed by warning labels and education for doctors and medical scans to identify patients at greater risk of stroke.


South Africa holds off Bangladesh, remains unbeaten in cricket’s T20 World Cup  

WESTBURY, New York — Spinner Keshav Maharaj bowled a six-run, two-wicket final over and South Africa held off Bangladesh by four runs to stay unbeaten in cricket’s T20 World Cup on Monday.

Bangladesh needed 11 from the last six deliveries to register a famous win, then needed a six off the last ball. Taskin Ahmed came to the crease after Bangladesh’s seventh wicket, and faced the last ball, a full toss by Maharaj. Ahmed swung and managed only one run.

On a typically tough batting pitch at Nassau County Stadium, South Africa successfully defended its lowly total of 113-6 and restricted Bangladesh to 109-7.

It was the lowest target — 114 — ever defended in a T20 World Cup, trumping India’s defense of 120 runs just the day before.

“That was not nice on the heart, but feels good that we got over the line,” said top-scorer Heinrich Klaasen, the player of the match. “This wicket is not great for stroke play. We got some information from the last game and applied it today. I think we got a decent total on the board. 

“We have had three pressure games now and I think we are through [to the next round].” 

Maharaj finished with 3-27 in four overs, while Kagiso Rabada (2-19) and Anrich Nortje (2-17) also bowled well.

South Africa firmed the top spot in Group D with three from three and was in pole position to secure a Super Eight spot. Bangladesh’s first loss in two matches kept it in second place.

South Africa chased down Sri Lanka and the Netherlands in its previous two matches at the ground and was made to bat first this time.

But it still fumbled another start. Pace bowler Tanzim Sakib trapped opener Reeza Hendricks for a golden duck and had Tristan Stubbs caught for a five-ball duck. 

Aiden Markram was bowled for 4. In between, Sakib bowled Quinton de Kock for 18 as the Proteas slumped to 23-4 in 4.2 overs.

David Miller came up with another rescue job after his half-century against the Netherlands. He scored 29 off 38 balls and put on 79 runs for the fifth wicket with Klaasen.

Klaasen top-scored with 46 off 44, including two fours and three sixes. The duo pushed South Africa past 100 before falling in the space of six deliveries.

The late strikes left South Africa hanging at just about a par total.

Bangladesh’s chase faltered at the start, too. It was down to 37-3 and then 50-4 at the halfway stage.

Nortje dismissed skipper Nazmul Shanto for 14, and sent back Shakib Al Hasan for just 3, picking up his eighth wicket in three games.

Litton Das was out caught off Maharaj, while Rabada had Tanzid Hasan caught behind for 9.

Towhid Hridoy and Mahmudullah put on 44 off 45 balls to bring Bangladesh back on track.

At 94-4 in the 18th over, Bangladesh was in the driver’s seat, then lost wickets rapidly to spiral out of control. It went from 94-4 to 108-7 in the space of 17 deliveries. 

Rabada returned to trap Hridoy but Maharaj’s left-arm spin turned the game in the final over.

South Africa completes the group stage against Nepal on Friday. Bangladesh has the Netherlands on Thursday. 


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Thousands turn out for LA Pride Parade, events

LOS ANGELES — Tens of thousands of people lined the streets of Hollywood on Sunday for the L.A. Pride Parade, one of the biggest events during a month of celebrations honoring the LGBTQ+ community in and around Los Angeles. 

Rainbow flags ruled the day as revelers cheered the lively procession that featured “Star Trek” star and activist George Takei as the Icon Grand Marshal. 

“As someone who has witnessed the struggles and triumphs of our community over the years, I am filled with gratitude for the progress we have made and inspired to continue the fight for full acceptance and equality for all,” Takei said in a statement. 

The parade’s Community Grand Marshal was L.A. Fire Department Chief Kristin Crowley. The department’s first openly gay chief said she was “overjoyed” by the honor. 

Following the parade, the L.A. Pride Block Party offered DJs, live performances, food trucks and a beer garden. 

On Saturday night, Latin pop superstar Ricky Martin headlined a concert dubbed Pride in the Park at Los Angeles State Historic Park. 

Other events scheduled for Pride Month include celebrations at Dodger Stadium and Universal Studios Hollywood. 


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US reconstructive surgeons step up to help Ukrainian counterparts

After Russia invaded Ukraine, the West responded, sending military weaponry and aid to the embattled nation. But as the war drags on, there is also a need for doctors. One nonprofit is sending American surgeons to Ukraine, and Ukrainian surgeons to train in the United States. Iryna Solomko has the story, narrated by Anna Rice. VOA footage by Pavlo Terekhov.