Protocols

Roche gets EMA recommendation for Ocrevus; Anthem now covers Sarepta’s exon-skipping Duchenne MD drug

→ The EMA’s Committee for Medicinal Products for Human Use has given a glowing recommendation for Roche’s multiple sclerosis drug Ocrevus (ocrelizumab), paving the way for marketing authorization in the EU. The brief announcement, which comes eight months after the FDA approval, notes that Ocrevus is the “first medicine to receive positive opinion for treatment of patients with early stage of primary progressive multiple sclerosis.” With a larger reach than its (many) competitors, the drug has been touted as a potential game changer.

→ Between an IPO and a global offering, French biotech Erytech Pharma has raised roughly $125 million today. The company — to be known as $ERYP on the Nasdaq, as it already is on Euronext Paris — offered 4.7 million American shares at $23.26, raising $109 million. This corresponds to €20 per share in the European private placement, which raised an additional $16 million. Most of the money will go to testing and developing its red blood cell cancer therapy eryaspase.

→ Health insurer Anthem has come around on Sarepta’s treatment for Duchenne muscular dystrophy, announcing it will cover Exondys 51 for ambulatory patients with a genetic mutation amenable to exon 51 skipping (around 13% of all DMD patients). The Six-Minute Walk Test (6MWT) will no longer be required to qualify for coverage. Broadening insurer coverage for this drug is central to Sarepta’s success as they study other drugs for DMD.



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