Brian Orelli of The Motley Fool highlights four drugs--AstraZeneca's Brilinta, Questcor's Acthar Gel, Savient's Krystexxa and Novartis' Gilenia--that could gain FDA approval this month despite some previous difficulties. However, given recent troubles with other approved drugs, the FDA's cautious nature could cause issues for some of the drugmakers.
Back in July, Brilinta received a 7-to-1 FDA panel vote to continue towards approval, despite American patients not reacting as well as 42 other countries' participants to the blood thinner compared to its competitor Plavix in its massive, 18,000 patient Phase III trial. The FDA is scheduled to make its decision Sept. 16.
Despite its previous setbacks, Questcor, one of Fierce's best pharma stocks of 2007, has received good news from the FDA recently. According to The Motley Fool, an FDA panel recently voted 20-to-1 and 22-to-1 in favor of Acthar's safety and efficacy. Similarly, Krystexxa, the gout drug, is returning to the FDA after manufacturing worries last year. Savient's stock prices have see-sawed based on FDA negative responses and positive remarks.
But Orelli is clear: if one of the four drugs need not worry about approval, it's Gilenia. The needle-free MS drug received a 25-0 endorsement from an FDA expert panel back in June, and just received approval in Russia.