Midway through 2007, the U.S. Food and Drug Administration has only approved one Biologic License Application for a biologic drug that has never before been marketed in the United States.

Alexion Pharmaceuticals' Soliris (eculizumab), approved by the FDA in March for treating the cardiovascular disease paroxysmal noctural haemoglobinuria (PNH), a rare type of blood disorder that can lead to disability and premature death, is the sole novel biologic drug approved thus far this year.

The pace is considerably slower than in 2006, when three novel biologics were approved in the first six months of the year.

Several biologics already on the market have been approved by the FDA in the first half of 2007 for new uses, but the slow pace of approval of novel biologics is a testament anew to the complexity of the challenge of developing these costly biologic treatments.

In contrast to the lone approval of a novel biologic drug, the FDA has thus far this year approved seven chemical drugs containing an active ingredient never marketed in the United States.

New chemical drugs approved by the FDA thus far this year include Vyvanse (lisdexamfetamine) for Attention Deficit Hyperactivity Disorder (ADHD); Tekturna (Aliskiren) for hypertension; Letairis (Ambrisentan) for hypertension; Tykerb (lapatinib) for breast cancer; Altabax (retapamulin), an antibacterial; Torisel (temsirolimus) for renal cell carcinoma; and Neupro (rotigotine) for treatment of Parkinson's Disease.