Biogen sees gradual Spinraza launch, eyes mid-year EU approval

Daily Mail

26 January 2017 - Biogen Inc said on Thursday that the first U.S. patients have received its new drug for the leading genetic cause of death in infants and that it anticipates mid-year approval of Spinraza in the European Union.

Health insurer Anthem Inc this month said it would limit Spinraza coverage to only the most severe patients, even though it received approval for all grades of spinal muscular atrophy.

The list price for Spinraza is a whopping $750,000 for the first year of therapy, dropping to about $375,000 a year after that. Insurers have been amenable to paying for very expensive drugs that extend lives in diseases with small patient populations.

But political and payer scrutiny of U.S. drug pricing has intensified with President Donald Trump recently accusing pharmaceutical companies of "getting away with murder."

Biogen said it has also filed for Spinraza approval in Japan, Australia and Canada and expects to meet with Japanese regulators in the coming days.

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Michael Wonder

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Michael Wonder