RE:RE:RE:RE:RE:RE:AstraZeneca's ADC disappoints - on severe adverse events Then there's Soliris, a drug cleared to treat four rare diseases that AZ picked up in its $39 billion buyout of Alexion. After its original 2007 approval in the rare chronic blood disorder paroxysmal nocturnal haemoglobinuria, the drug scored a new use in rare autoimmune disease neuromyelitis optica spectrum disorder more than a decade later in 2019.
Under the IRA Soliris’ continued development would have to occur in new indications to achieve market exclusivity and not as continued development in the orginal indications, unless the drug is combined with a new biologic like pelareorep, for example, much like a PD-1 checkpoint inhibitor or small molecule PARP inhibitor being combined with ONCY's oncolytic virus pelareorep.