The approval in July of AstraZeneca’s Brilinta (ticagrelor) brings to 21 the total of new drugs approved by the US Food and Drug Administration (FDA) in 2011 so far, which is equal to the total of all new drugs it approved last year, says a new report.
With the approval of Brilinta, AstraZeneca’s potential blockbuster blood-thinner that will compete against Sanofi/Bristol-Myers Squibb’s Plavix (clopidogrel), “we’re on our way to breaking the anaemic pace of new drug approvals of recent years,” says Steven Burrill, chief executive of life sciences financial services firm Burrill & Co.
However, he adds that the problems underlying the relatively low rate of approvals since 2004 still need to be addressed.
“The industry has to reverse a long-term decline in R&D productivity. And the FDA has to find a way to ensure the safety of new drugs while not slowing the introduction of new and needed therapies or creating undue burdens for developers,” says Mr Burrill.
The FDA has already approved a number of important new drugs so far this year, the report notes. These include: – Vertex Pharmaceutical’s hepatitis C drug Incivek (telaprevir); – BMs’ Yervoy (ipilimumab), the first new melanoma drug for 13 years and the first to extend the lives of patients with late-stage disease; and – Human Genome Sciences’ Benlysta (belimumab), the first new drug for lupus in 50 years.
More than a dozen other drug candidates are scheduled for review before year-end, including Seattle Genetics’ Adcetris (brentuximab vedotin), a first-in-class cancer drug that uses an antibody to target cancer drugs with a cytotoxic payload. An FDA advisory panel voted to recommend approval for the drug last month, and a decision by the agency is due before the end of the year.
While it is not clear what has driven this increase in approvals, Mr Burrill says an analysis by his firm has found that one-third of the drugs approved this year had failed to satisfy the agency on their first attempt, compared to about one-fifth of the products approved in 2010.
Seven months of data is not enough to suggest a significant change in approach at the FDA or that strategies to alter the drug development process to improve productivity are paying off, Mr Burrill cautions. “It is encouraging. But improving the pace at which new drugs reach the public will require much more work, both at the agency and in industry,” he says.
