The devastating natural course of atypical hemolytic uremic syndrome, coupled with the small quantity of drug used to treat pediatric patients, means the new use is expected to have only a small impact on sales initially, Alexion's management says.
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While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
