Alexion Pharmaceutical Inc.’s drug Soliris has won U.S. Food and Drug Administration approval as a potential treatment for patients with Myasthenia Gravis, the company announced Monday.
Meanwhile, another Elm City biotech, Biohaven Pharmaceuticals, got the green light to test its brain disorder drug trigriluzole for treatment of Obsessive Compulsive Disorder.
Alexion’s Soliris is now the first FDA-approved treatment in more than 60 years for patients with Generalized Myasthenia Gravis (gMG), a severe form of the debilitating neuromuscular disease, said Nancy Law, CEO of the Myasthenia Gravis Foundation of America. The progressive disease causes weakness of the eye, head, neck, trunk, limb and respiratory muscles.
“(T)his approval of Soliris will provide a new option for those with gMG and especially for those who do not respond adequately to or cannot tolerate standard treatment options,” Law said.
Soliris performed well in clinical trials for patients with the anti-AchR antibody-positive form of the disease who failed to respond to other treatments, about 5 to 10 percent of all Myasthenia Gravis sufferers, the company said in a news release.
The approval comes amid a year of controversy for Alexion, which recently faced an exodus of top executives, an internal probe into sales practices and a federal probe of its support for charities that aid Medicaid patients. The company will be moving its New Haven headquarters to Boston by mid-2018 but will maintain a research presence in the Elm City.
Also Monday, Biohaven announced it would move forward this quarter with a Phase 2/3 clinical trial of trigriluzole for patients with OCD, a condition marked by intrusive thoughts and repetitive behaviors, after getting the OK to proceed from the FDA.
Natalie Missakian can be reached at news@newhavenbiz.com
