(Reuters) -Biogen said on Monday its drug for treating a rare genetic disorder that causes progressive damage to the nervous system has won European health regulator’s approval for use in adults and adolescents aged 16 years and older.
The approval, the first for patients with Friedreich’s ataxia in the European Union, was based on a mid-stage study that showed patients who took Biogen’s Skyclarys experienced an improvement in neurological functions such as speaking, swallowing and standing, compared to a placebo.
Skyclarys is also the first U.S. health regulator-approved treatment for the disease that affects about one in every 50,000 Americans, according to data from the National Institutes of Health.
The progressive disease causes muscle weakness, loss of coordination and can lead to patients being bound to a wheelchair in 10 to 20 years following their diagnosis.
Biogen gained access to Skyclarys in a $6.5 billion acquisition of Texas-based Reata Pharmaceuticals, the drugmaker’s first large acquisition under CEO Christopher Viehbacher, last year.
Since Viehbacher took the helm at Biogen in late 2022, the drugmaker has also cut jobs and launched a review of its biosimilars business to return it to growth.
The company has been betting on its Eisai partnered Alzheimer’s disease drug Leqembi, postpartum depression drug Zurzuvae and Skyclarys to drive growth in the second half of this decade as older treatments face increased competition and patent losses.
Massachusetts-based Biogen, which is set to report its fourth-quarter results on Tuesday, has warned its annual profit forecast would be dragged by higher expenses associated with Reata acquisition.
(Reporting by Pratik Jain in Bengaluru; Editing by Shinjini Ganguli)
Source link : https://www.medscape.com/s/viewarticle/biogens-rare-genetic-disorder-drug-gets-approval-eu-2024a100031h?src=rss
Publish date : 2024-02-12 21:20:51
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