So far, the Food and Drug Administration (FDA) has only ticked off seven drugs that contain an active ingredient never marketed in the US, so-called New Molecular Entities (NMEs), or Biologic License Application (NBA) applications. This is compared to eleven in the first six months of 2006 (three of which were NBAs).
Over the past decade or more, there has been a general, well-known, industry trend of increasing research and development (R&D) costs not being reflected in the number of new drug approvals. While pharma companies work out how to best deal with the problem, the pattern seems set to continue.
A recent US Government Accountability Office report (GAO) revealed that between 1993 and 2004, R&D spending went up 147 per cent to $40bn (€29bn) but the number of New Drug Applications (NDAs) only increased by 38 per cent. Most of those were for modifications to existing drugs; the number of NME applications only increased seven per cent.
The innovative drugs passed by the FDA this year are: New River Pharmaceuticals' (now acquired by Shire) Vyvanse (lisdexamfetamine) for Attention Deficit Hyperactivity Disorder (ADHD); Tekturna (Aliskiren) from Novartis and Speedel, which treats hypertension; another high blood pressure drug from Gilead called Letairis (Ambrisentan); GlaxoSmithKline (GSK) had its breast cancer drug Tykerb (lapatinib) approved plus its antibacterial Altabax (retapamulin); Wyeth's Torisel (temsirolimus) for renal cell carcinoma; and Alexion Pharmaceuticals Soliris (eculizumab) to treat the cardiovascular disease paroxysmal noctural haemoglobinuria (PNH).
The FDA actually approved an eighth NME from Schwarz Pharma that is labelled to treat Parkinson's disease through its mechanism as a dopamine agonist. However, Neupro (rotigotine) had already been approved in Europe last year.
Outside of the US, Biocon had its antibody approved by Indian regulators. BIOMAb-EGFRTM inhibits epidermal growth factor receptor (EGFR) and will be used intitially to treat head and neck cancer. It is also in label-expansion trials for colorectal cancer, lung cancer, glioma and pancreatic cancer.