Diabetes Combos: Novo, Sanofi May Need New Treatment Paradigm To Match Products
Stepwise approach of endocrinologists may have to change to maximize uptake of insulin/GLP-1 combinations.
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FDA request for more information on pen injector forces three-month review extension, offsetting advantage from priority review voucher redemption.
After a long wait, lixisenatide has little to distinguish itself from the five GLP-1 products already on the market.
Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.