Approval came via FDA’s accelerated pathway, which allows drugs to launch based on promising early results, before they’re confirmed to benefit patients.
The FDA is requiring Biogen to continue studying the drug in a trial of people who carry the genetic mutation but do not yet have ALS symptoms.ALS patients hope the decision could lay the groundwork for more expedited approvals to fight the disease, which affects 16,000 to 32,000 people in the U.S. The FDA has long used accelerated approval to speed the availability of drugs for cancer and other deadly conditions.
The drug, tofersen, is designed to block the genetic messengers that produce a toxic form of protein that is thought to drive the disease in about 2% of ALS patients. Cambridge, Massachusetts-based Biogen will sell it under the brand name Qalsody. Patients receive three initial spinal injections of the drug over a two-week period, followed by a monthly dose. The most common side effects linked to the drug were pain, fatigue and increased spinal fluid.
México Últimas Noticias, México Titulares
Similar News:También puedes leer noticias similares a ésta que hemos recopilado de otras fuentes de noticias.
FDA grants accelerated approval for Biogen ALS drug that treats rare form of the diseaseThe FDA's approval requires Biogen to further study its ALS drug tofersen to further verify its clinical benefits.
Leer más »
FDA grants accelerated approval to Biogen’s treatment for rare form of ALSThe U.S. Food and Drug Administration said Tuesday it has granted accelerated approval to Biogen Inc.’s torferson, a treatment for a rare form of amyotrophic...
Leer más »
FDA grants accelerated approval to Biogen treatment for rare form of ALSThe FDA has deemed Biogen's torferson reasonably likely to produce a clinical benefit for patients.
Leer más »
'Stamp of approval': Twitter's Musk amplifies misinformationElon Musk promised to make Twitter the 'most accurate source of information about the world,' but he has repeatedly used his own account to amplify false claims from some of the most notorious disinformers on the internet, according to an AFP analysis of his online activity.
Leer más »
Biden’s approval rating drops among young Americans to 36%: pollThe national poll, put out by the Institute of Politics at Harvard Kennedy School, found 36% of registered voters aged between 18 and 29 years currently approve of the 80-year-old president’s…
Leer más »
Biden to tee up reelection bid facing lagging approval ratings, staff upheaval and wariness over agePresident Biden is poised to announce his reelection campaign Tuesday, despite low approval ratings and a string of polls showing most Americans and half of Democrats do not think he should run again, signaling a potential enthusiasm gap for the oldest president in history.
Leer más »