Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a block­buster rare dis­ease gi­ant in its sights in Alex­ion’s Soliris, small biotech Apel­lis has rea­son to think its com­peti­tor is wor­thy of the spot­light. Now, with the FDA on its side, Apel­lis will get its chance to be the David to Alex­ion’s Go­liath.

The FDA on Fri­day ap­proved Em­paveli (pegc­eta­coplan), a C3 com­ple­ment in­hibitor the biotech thinks can prove a wor­thy chal­lenger to Alex­ion’s C5 in­hibitors Soliris and fol­low-up drug Ul­tomiris in rare dis­ease parox­ys­mal noc­tur­nal he­mo­glo­bin­uria (PNH).

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.