Nelson Vergel
Founder, ExcelMale.com
An independent panel of experts to the U.S. Food and Drug Administration (FDA) will discuss Sarepta Therapeutics Inc's muscle wasting drug on April 25, nearly three months after the original date.
The agency on Jan. 20 postponed the meeting evaluating the company's keenly watched Duchenne muscular dystrophy drug, eteplirsen, due to an inclement weather forecast for Washington DC. (1.usa.gov/24T8HOa)
FDA staff on Jan. 15 had said they were unconvinced about eteplirsen's efficacy and trial design, a day after the regulator rejected Kyndrisa, a rival drug developed by BioMarin Pharmaceutical Inc.
Eteplirsen, like Kyndrisa, is designed to treat a subset of patients with DMD, which hampers muscle movement and affects one in 3,600 newborn boys, with most patients dying by the age of 30.
http://mobile.reuters.com/article/idUSKCN0WC2FG
The agency on Jan. 20 postponed the meeting evaluating the company's keenly watched Duchenne muscular dystrophy drug, eteplirsen, due to an inclement weather forecast for Washington DC. (1.usa.gov/24T8HOa)
FDA staff on Jan. 15 had said they were unconvinced about eteplirsen's efficacy and trial design, a day after the regulator rejected Kyndrisa, a rival drug developed by BioMarin Pharmaceutical Inc.
Eteplirsen, like Kyndrisa, is designed to treat a subset of patients with DMD, which hampers muscle movement and affects one in 3,600 newborn boys, with most patients dying by the age of 30.
http://mobile.reuters.com/article/idUSKCN0WC2FG
