Drug cocktails for cancer, heart disease and other conditions may reach the U.S. market sooner under new guidelines that let companies seek approval for a combination of two or more medicines at the same time.
The path will be reserved for serious illnesses where a combination therapy is needed to overcome resistance or weak response to only one medicine, according to draft guidelines the Food and Drug Administration released today. Previously, the merit of each compound had to be first proven on its own.
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. A streamlined FDA review may shave five years off development and improve treatment, Ira Mellman, head of cancer research at Roche’s Genentech unit, estimated this year.
“We expect increasing use of combinations,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said today at the Partnering for Cures meeting in New York. “This isn’t just true of cancer. It’s going to be true of many serious diseases.”
Scientists are focusing more on specific genes that diseases target and identifying compounds that alter these molecular pathways. Combining targeted therapies may make it more difficult for diseases to evolve and resist treatment.
Combinations in Development
Roche, based in Basel, Switzerland, has a combination that began safety tests in patients this year. New York-based Pfizer Inc., Merck & Co. and AstraZeneca Plc are studying combinations. Novartis, also of Basel, and London-based GlaxoSmithKline Plc started two studies this year combining an experimental drug from each company. Sanofi, of Paris, has licensed molecules that may work together to fight cancer.
Patient groups urged the FDA to help speed development of these products, Woodcock said. The draft guidelines lay out what types of studies would support approval. The agency will accept public comments until Feb. 14, and a final version may be released within six months, Woodcock said.
While the guidelines may speed development of a combination owned by one company or an existing partnership between companies, they won’t eliminate challenges that often prevent drugmakers from working together or with academic researchers, according to Michael Caligiuri, director of Ohio State University’s Comprehensive Cancer Center in Columbus.
“Generally speaking when you’re co-developing agents, it involves two companies and the biggest hurdle is the legal one, not the scientific one,” Caligiuri said today in a telephone interview. “That is very often a showstopper.”
Woodcock said that the agency “can open the door with guidance but” companies developing drugs “have to want to do this.”
Partnering for Cures is sponsored by the Milken Institute’s FasterCures nonprofit research organization in Washington.
To contact the editor responsible for this story: Reg Gale at email@example.com.