Good news on the drug-approval front. Through the end of July, FDA’s Center for Drug Evaluation and Research had approved 21 new drugs (new molecular entities and new biologics license applications), which equals the total number of new drugs approved in all of 2010. Although not enough to claim a reversal of the recent downward trend in drug R&D productivity, the numbers are a good sign for the industry.
Some key drug approvals thus far in 2011 include AstraZeneca’s Brilinta (ticagrelor), a cardiovascular drug, which is being positioned as a potential blockbuster to complete against the platelet inhibitor Plavix (clopidogrel) by Bristol-Myers Squibb and Sanofi, according to an Aug.1, 2011, press release by Burrill & Company, a life-sciences financial-services firm. Plavix was the second highest selling drug in 2010 on a global basis, trailing only Pfizer’s Lipitor (atorvastatin), which was the top-selling drug. In 2010, Plavix posted global sales of $8.8 billion, according to IMS Health.
Other key approvals thus far in 2011 were: Incivek (telaprevir), a hepatitis C drug by Vertex Pharmaceuticals; Yervoy (ipilimumab), a melanoma drug by Bristol-Myers Squibb; and Benlysta (belimumab), a lupus drug by Human Genome Sciences, noted the Burrill & Company analysis. More than a dozen other drug candidates are scheduled for FDA review by the end of the year, according to the Burrill analysis.
As noted by Burrill & Company, seven months of data in terms of approvals does not in of itself make a change in terms of improved R&D drug productivity, but at least it is a positive sign. During the past five years (2006–2010), FDA has approved on average 22 new drugs per year (21 in 2010, 26 in 2009, 24 in 2008, 18 in 2007, and 22 in 2006), according to FDA information. The recent 10-year high was in 2004, when FDA approved 36 new drugs.
It is not likely that in 2011 or in the near term, the industry will reach the level of productivity achieved in 2004, but at least thus far in 2011, there is good news on the drug-approval front.