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Sarepta fails obtain support eu new:
Sarepta Therapeutics failed to convince the European drug regulator to approve its gene therapy against muscle disorders on Friday. Nevertheless, while the company faces increased regulatory monitoring after two recent deaths of patients related.
The title of the company based in Cambridge, in the Massachusetts, dropped by 11 %. For example, Since the start of the year, the action has lost 88.8 % of its value.
The negative opinion of the European Committee for Elevidys constitutes a new major setback for Sarepta. which was ordered earlier this month by the American health agency to cease any expedition of its gene therapy-the only approved to date for the treatment of Duchenne muscular dystrophy (DMD).
Sarepta had already suspended the administration of treatment in non-ambulatory patients. that is to say unable to walk independently, and then complied with the demand for American Food sarepta fails obtain support eu new and Drug Administration (FDA) to break all expeditions, in collaboration with Roche, its partner outside the United States.
“Although we are disappointed with the negative opinion of the CHMP (Committee of Medicines for Human use). we understand the urgency of continuing dialogue and collaboration in order to provide transformative therapies to people with Duchenne,” said Louise Rodino-Klapac, director of research and development at Sarepta.
The DMD mainly affects men, affecting 1 in 5,000 boy at birth in the world. The average life expectancy for people with this disorder is 22 years.
According to analyst Sami Corwin. from the office William Blair, the drop in the Sarepta title reflects the decrease in potential income from steps or future royalties on the part of rock.
“Even if we think that it is possible that the suspension of Elevidys’ expeditions to the United States is lifted by the end of the year. specifically sarepta fails obtain support eu new for young ambulatory patients, uncertainty will continue to weigh on action,” he added.
Roche said on Friday to continue dialogue with the European Medicines Agency to explore a potential path to make. Elevidys available in the EU.
The Swiss laboratory believes that the benefit/risk ratio remains positive in ambulatory patients.
Sarepta said he continued working with the FDA in the United States to respond to recent concerns about Elevidys’s security.
Sarepta fails obtain support eu new
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