FDA seeks comments: co-development of two or more investigational drugs to be used in combination
This article was originally published in Scrip
The US FDA is establishing a public docket to obtain input on methods to co-develop two or more distinct investigational drugs intended to be used in combination to treat a disease or condition (but not as a fixed-dose combination), according to a Federal Register announcement posted 8 June.
The regulator anticipates that there will be general methodologic or regulatory issues that will arise. The areas most likely to be affected include oncology, anti-infectives, seizure disorders and cardiovascular diseases. The agency said it had seen interest by sponsors in obtaining information on study designs and appropriate populations for developing two or more novel, direct-acting antivirals intended to be used in combination for the treatment of chronic hepatitis C. It is also aware of efforts to try to develop two or more investigational drugs intended to be used in combination to treat tuberculosis.
As one example, the agency said that it seeks comment on issues arising from co-development of two or more drugs intended to be used in combination where one or more of the drugs is intended to enhance the effectiveness of the other, but one or more of the drugs does not or may not have an independent therapeutic effect, including relevance and utility of clinical or animal findings for either drug alone.