Speedier development and regulatory process contributed to a peak in product approvals in 2015
By Lisa M. Jarvis

For the second year in a row, new drug approvals in the U.S. arrived at a blistering pace. Forty-five new products received the Food & Drug Administration’s green light in 2015, making it the most productive year for the pharmaceutical industry since 1996. But unlike in 2014 <http://cen.acs.org/articles/93/i5/Year-New-Drugs.html> , when the quality of the therapies was as impressive as the quantity, few products approved in 2015 stood out as major breakthroughs. Rather, many of the new drugs were notable more for their breathtaking price tags and how swiftly they moved to the market than for their ability to transform lives. The bounty of new drugs in 2015 included more biologics than in the previous two years: A third of the drugs approved were antibodies, peptides, or enzymes compared with about a quarter in 2014. The year’s class included fewer novel mechanisms of action—36% of approvals compared with 42% in 2014. Although big innovations were in short supply in 2015, the nearly two-decade peak in approvals buoyed spirits in the industry. Twenty years after the sequencing of the human genome promised a new way to cure disease, “it really feels like we’re in a period and will continue to be in a period where
breakthroughs are turning into new medicines,” says Glen Giovannetti, global life sciences leader at Ernst & Young. Aside from the sheer number, the most notable feature of last year’s approval list might be the speed with which the drugs reached the market. FDA granted one or more forms of expedited review—which include priority review, accelerated approval, and orphan drug status—to 60% of the drugs approved in 2015. At the same time, more New Drug Applications are getting FDA’s rubber stamp on their first try. Last year 39 drugs, or 87%, were approved in the first cycle—meaning the agency did not ask companies for more information that would extend the review time. In 2010, just 56% of new drugs were approved in the first cycle. FDA attributes the improved success rate to factors such as better interactions with companies early in the development process, fewer me-too drugs, more targeted therapies, and more drugs for rare disease in which greater risk is tolerated. That so many drugs were approved—and so many made it through the regulatory gantlet on their first try—is important affirmation of a changing attitude at FDA, Giovannetti says. Given that companies’ relationships with the agency once seemed adversarial, “the impression that regulators are interested in getting good drugs to patients is positive,” he adds. One of the biggest recent changes at FDA was the introduction in 2012 of “breakthrough therapy designation.” Companies developing drugs that FDA considers to be truly innovative —ones with a new mechanism of action or that address a disease that currently lacks treatment options—receive extra guidance from agency staffers early in the development process. Companies and industry watchers are now trying to gauge how much time breakthrough status can shave from the lengthy drug development process. Between 2002 and 2013, it took an average of 7.5 years for a drug to go from Investigational New Drug Application—a request for FDA’s permission to start human studies—to regulatory approval, according to the Tufts Center for the Study of Drug Development. By comparison, the 11 drugs with breakthrough status approved in 2013 and 2014 took an average of 5.2 years to go from application to market. And the three drugs out of those 11 that had the status plus a second expedited status sailed to market in just 4.3 years.The data set is small, stresses Christopher Milne, director of research at the Tufts center, but so far the time saved with breakthrough status—potentially more than three years—is huge. Tufts is waiting for a larger cohort of drugs approved with the designation before doing a complete analysis. One reason it’s hard to draw definitive conclusions about the impact of the breakthrough designation is that many drugs lingered in the pipeline before companies got extra guidance from FDA. Of the 10 products with breakthrough status that were approved in 2015, six had already been in the clinic for at least four years before the special designation was introduced. But the four companies that received the status early on in a drug’s development clearly benefited from closer FDA guidance. For example, Boehringer Ingelheim’s Praxbind, an antibody fragment that reverses the activity of the company’s blood thinner Pradaxa, went into the clinic in 2012, was granted the status in 2014, and won approval a year later.

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