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Sharp Dip in US Drug Approvals is Forecasted


According to World News (27 July 2012), a study published by from Fitch Ratings has predicted that the FDA will approve fewer novel drugs in 2012 than it did last year. Despite a strong first quarter, with eight New Molecular Entities (NMEs) approved, the total of 14 new approvals in first-half 2012 lags behind the 18 new approvals in the same period of 2011.


2011’s unusually high number of registrations is now nearing fruition, with 13 NMEs currently under review at the US FDA or the European Medicines Agency (EMA), with expectations of full marketing approval over the next few quarters.


Filings with the FDA and/or EMA are planned this year for the following 12 NMEs:


  1. Bayer’s alpharadin for bone metastases in prostate cancer and regorafenib for metastatic colorectal cancer;
  2. GlaxoSmithKline’s IPX066 for Parkinson’s disease and Revolair for chronic obstructive pulmonary disease;
  3. Johnson & Johnson’s canagliflozin for type 1 diabetes;
  4. Merck & Co’s Bridion for reversal of neuromuscular blockade and suvorexant for insomnia;
  5. Pfizer’s Aprela for relief of menopausal symptoms;
  6. Roche’s trastuzumab-DMI for metastatic breast cancer; and
  7. Sanofi’s Kynamro (mipomersen) for familial hypercholesterolemia, iniparib for breast cancer and Lyxumia (lixisenatide) for diabetes.


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