US Regulatory Trends During 2010: A Rapidly Changing Environment

A Rapidly Changing Environment Current Landscape The US Food and Drug Administration (FDA) approved 21 new molecular entities (NMEs) in 2010, the lowest since 18 new drugs were approved in 2007.

Despite this drop in registrations, BMI notes that five potential blockbusters received approval during 2010, highlighting promising revenue growth opportunities for the drugmakers concerned: Genentech, Novo Nordisk, Amgen, Novartis and Dendreon.

Of the potentially new blockbuster drugs approved, most are biological therapies, including Agmen’s Prolia (denosumab) to treat osteoporosis in menopausal women, Genentech’s Actemra (tocilizumab) to treat rheumatoid arthritis, and Dendreon’s Provenge (sipuleucel-T), an immunetherapy for prostate cancer.