FDA approvals decline, focus shifts to specialty-care drugs

Only 21 new products were approved last year, but the number of applications submitted for approval was also at a low. Also in 2010, firms continue to move away from blockbuster primary-care drugs.

In 2010, the Food and Drug Administration approved 21 new products.

This included Genentech’s Actemra for rheumatoid arthritis, Novartis’s Fingolimod for multiple sclerosis, and Amgen’s Denosumab for postmenopausal osteroporosis (which analysts are predicting sales of over $1 billion). For the full list, click here [pdf].

According to the FDA report [pdf], this is a decline from 2009’s 26 approvals and 2008’s 24. But since 2001, the FDA’s Center for Drug Evaluation and Research (CDER) has averaged about 23 approvals per year, slightly higher than last year’s approvals.

However, it appears that the number of applications for approval is what’s really declining.

Last year, CDER received 23 applications, a drop from 2009’s 37 and 2008’s 34. In fact, fewer applications were filed in 2010 than almost any other year for the last 15 years.

If the number of applications don't increase, CDER doesn't expect to see much of a year-to-year increase in approvals. And so, drugmakers and biotechs may complain the FDA is not moving quickly enough, but then, neither are they [Pharmalot].

Regardless of the proportions of applications to approvals, one of the biggest trends in 2010 was “the continued shift from primary care to specialty care,” says Ernst & Young analyst Andrew Jones. In the past, pharmaceutical companies sought blockbusters among primary-care drugs for mass-market indications – such as Pfizer’s cholesterol-lowering Lipitor (atorvastatin) or AstraZeneca’s proton pump inhibitor Nexium (esomeprazole).

Nature Reviews Drug Discovery explains:

Increasingly, however, firms are moving towards specialty-care and orphan-disease markets. The roster of newcomers in 2010, for instance, includes five orphan drug products and several ‘specialty care’ products (such as Shire’s velaglucerase alfa for Gaucher’s disease, Theratechnologies’ tesamorelin for HIV lipodystrophy and Merz’s IncobotulinumtoxinA for cervical dystonia and blepharospasm).

“What we’re seeing is a result of prior investment into areas where companies believe they can deliver meaningful improvements to patient outcomes and provide a good evidence base to satisfy payers,” says Jones. “This trend is really about payer dissatisfaction with high prices for what might have in the past been incremental innovation and ‘me too’ products, as well as saturation in some disease areas by innovative products and generic versions that already do the job pretty well.”

As payers question what they're getting for their money, drug firms are increasingly taking reimbursement issues into account and seeing scope to deliver improvements to expensive treatment paradigms for chronic diseases, according to Christopher Milne of the Tufts Center for the Study of Drug Development.

For example, experts predict that over the next few years within the oncology (or tumor) sector – the dominant area for approvals –more targeted drugs will emerge, affecting smaller patient populations. Such as Pfizer’s crizotinib, which has a target population of about 5% of people with non-small cell lung cancer (NSCLC) – the most common type of lung cancer.

Image: FDA

This post was originally published on Smartplanet.com

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