(Reuters) -Amylyx Pharmaceuticals Inc said on Tuesday that a European regulatory panel had taken a negative view on its amyotrophic lateral sclerosis (ALS) treatment, stalling the company’s plans on introducing its first commercial drug in the region.
Amylyx said the European Medicines Agency’s committee was “trending toward a negative opinion” on the marketing application for the drug.
The company plans to request a formal re-examination procedure in case the drug gets an unfavourable response from the committee in its June meeting. The European Commission will make a final decision based on the committee’s opinion.
The drug is already approved in the United States, based on data that showed it slowed progression of the disease and extended life expectancy by nearly 10 months in a mid-stage trial.
A panel of outside advisers to the FDA had recommended against the approval of the drug in March 2022, but the panel voted in its favor after it reconvened to look at new analysis of that data.
ALS is a rare neurological disease that affects nearly 29,000 people in the U.S. and more than 30,000 people in Europe, according to the company.
Amylyx’s drug has also been granted conditional approval in Canada.
Shares were down about 1% in early trading, after falling as much as 16.8% before the bell.
(Reporting by Raghav Mahobe in Bengaluru; Editing by Vinay Dwivedi)
Source: Read Full Article
