FDA highlights drug cocktails on the menu

US regulators issued draft guidelines for companies who want to combine two or more drugs into one therapy. This could speed up the development of drug cocktails to treat heart disease or late-stage cancer.
Written by Janet Fang, Contributor

Yesterday, the Food and Drug Administration issued the long-awaited draft guidelines for companies who want to combine two or more drugs into one therapy.

Each compound in a cocktail used to be judged individually first. But now, drug companies can seek approval for a combination, speeding up the development of cocktails to target severe illnesses like heart disease or late-stage cancers.

Increasingly, drugmakers have focused on “using combinations of drugs directed at multiple therapeutic targets to improve treatment response or minimize development of resistance,” the guidelines say.

To that end, big companies have even started teaming up.

In June 2009, Nature News reported that pharmaceutical giants AstraZeneca and Merck & Co. announced plans to collaborate to test a combination therapy comprising two early-stage cancer drug candidates: AstraZeneca's AZD6244, which targets a protein called MEK, and Merck's MK-2206, a compound that blocks a protein called AKT. The hope is that blocking both MEK and AKT can simultaneously shut down an escape route cancer cells use to become resistant to the drugs when they are used alone [Nature News].

However, the practice of turning your fierce competitor into a compatriot has remained uncommon because these companies were unsure of how the FDA would evaluate combination therapies (in addition to the science, business and legal aspects, of course).

Historically, each drug would need to have its own complete evaluation, making the cost of testing drug cocktails huge, while also slowing down the development time.

Not so with the new guidelines.

According to Genentech's head of cancer research, Ira Mellman, the new pathway could trim five years off of combination-therapy development.

Roche Holding AG, Novartis AG and Sanofi-Aventis SA are developing a new generation of medicines that work in tandem to suppress cancer similar to how drug cocktails have fought AIDS since the 1990s [Bloomberg].

The Wall Street Journal writes:

The guidelines acknowledge that when companies develop two or more drugs together, there is less safety and efficacy information available for each individual drug. So there have to be good reasons for FDA to sign off on the idea — the combination should be developed for use against a serious disease. The guidelines also urge companies to present data in lab studies or animals that show the combination therapy is more effective or provides a longer-lasting response compared to either of the drugs alone.

“We’re looking for the home run here,” says Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.

The draft “Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination” is open for public comment until 14 February, and a final version is expected in six months.

Image by incurable_hippie via Flickr

This post was originally published on Smartplanet.com

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