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Drug Withdrawal

All articles tagged with #drug withdrawal

health-medicine1 year ago•2 min saved

Amylyx Pharmaceuticals to Remove ALS Drug Relyvrio from US Market Following Failed Clinical Trial

Amylyx Pharmaceuticals will pull its drug, Relyvrio, from the US market after a study showed it didn't benefit patients with ALS. The drug's failure is a disappointment for patients and advocates, leaving only three ALS medicines available in the US. The company will also lay off 70% of its employees and continue studying Relyvrio and another experimental drug for rare diseases. The FDA had granted full approval for Relyvrio based on preliminary data, and the drug's withdrawal resolves a potential regulatory dilemma. ALS is a deadly disease with few treatment options, and Relyvrio's high price and disappointing sales have contributed to the decision to remove it from the market.

via The Associated Press|

#als #amylyx-pharmaceuticals #clinical-trial

health-medicine1 year ago•2 min saved

Failed ALS Drug Relyvrio to be Pulled from Market by Amylyx

Amylyx Pharmaceuticals will pull its drug Relyvrio from the US market after a study showed it didn't benefit patients with ALS. The company will halt sales and marketing in the US and Canada, and new patients will no longer be able to get a prescription. Patients already taking the therapy can enroll in a program to receive it for free. The drug's failure is a disappointment for patients and advocates, leaving just three ALS medicines available to US patients. Amylyx also plans to lay off 70% of its employees and continue studying Relyvrio and another experimental drug for rare diseases.

via ABC News|

#als #amylyx-pharmaceuticals #drug-withdrawal

health1 year ago•2 min saved

Amylyx Announces Withdrawal of ALS Drug Relyvrio and Workforce Reduction

Amylyx Pharmaceuticals has announced the withdrawal of its A.L.S. drug, Relyvrio, from the market in the United States and Canada after a large clinical trial found that the treatment did not work any better than a placebo. The drug, approved by the FDA in 2022, was one of the few treatments available for A.L.S., a severe neurological disorder. Patients currently taking the medication can transition to a free drug program, while new patients will no longer be able to start the treatment.

via The New York Times|

#als #amylyx-pharmaceuticals #clinical-trial

healthcare1 year ago•0 min saved

"FDA-Approved ALS Drug Relyvrio Withdrawal Looms After Amylyx's AMX0035 Fails Global Phase 3 Trial"

Despite the FDA's reluctance to pull fully-approved drugs from the market, the significant failure of Amylyx's Phase III data in ALS, with a failed primary endpoint and missed secondary endpoints, may leave the company with few options, especially considering past promises to consider withdrawing the drug if the final-stage study didn't succeed.

via Endpoints News|

#als #amylyx #drug-withdrawal

health-pharmaceuticals1 year ago•0 min saved

Amylyx's ALS Drug Relyvrio Fails Phase 3 Trial, Potential Market Withdrawal

Amylyx's FDA-approved ALS drug, Relyvrio, has failed a crucial Phase III trial, prompting the company to consider withdrawing the drug. In a study of 664 ALS patients, the drug did not outperform a placebo and missed all secondary outcomes, including quality-of-life assessments and muscle function. The failure puts access to the drug in jeopardy and is a significant setback for the treatment of the neurodegenerative disease.

via Endpoints News|

#als #amylyx #drug-withdrawal

health2 years ago•2 min saved

FDA pulls unproven premature birth drug Makena from market.

The FDA has ordered the immediate withdrawal of Makena, a drug intended to prevent premature births, from the US market after data showed it doesn't help pregnant women. Swiss drugmaker Covis Pharma had tried to keep the drug on the market while conducting additional studies, but the FDA rejected this proposal. Makena was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries. The FDA expedited Makena's approval in 2011 based on a small study, but a larger study completed in 2018 showed the drug neither reduced premature births nor resulted in healthier outcomes for babies.

via The Associated Press|

#covis-pharma #drug-withdrawal #fda

health2 years ago•2 min saved

FDA removes only preterm birth drug from market

The FDA has ordered the immediate withdrawal of Makena, a drug intended to prevent premature births, after data showed it doesn't help pregnant women. Swiss drugmaker Covis Pharma had repeatedly tried to keep the drug on the market while conducting additional studies, but the FDA rejected this proposal. Makena was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries. The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy.

via NBC News|

#covis-pharma #drug-withdrawal #fda

health2 years ago•2 min saved

FDA pulls unproven premature birth drug Makena from market.

The FDA has ordered the immediate withdrawal of Makena, a drug intended to prevent premature births, from the US market after data showed it doesn't help pregnant women. The medication was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries. The injectable drug is a synthetic version of the hormone progesterone, which can cause side effects, including blood clots, depression and allergic reactions. The FDA expedited Makena's approval in 2011 based on a small study suggesting it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term.

via ABC News|

#drug-withdrawal #fda #health