Kitov Pharma Ltd said the U.S. Food and Drug Administration approved its Consensi tablets to treat pain from osteoarthritis, the most common form of joint inflammation, and hypertension.
Consensi tablets, approved in three dosages, is a combination of already approved osteoarthritis treatment celecoxib and hypertension drug amlodipine besylate.
Hypertension is a common side effect of stand-alone drugs that treat osteoarthritis pain, and the combination drug is expected to treat both the conditions simultaneously.
The new drug application included results from a late-stage study showing Consensi reduced systolic blood pressure by a comparable amount versus amlodipine besylate.
The Israel-based company said over 50 million people in the U.S. suffer from osteoarthritis and about one of three adults, or about 75 million people, have high blood pressure.
Kitov Pharma has entered licensing agreements with Hebei Changshan Biochemical Pharmaceutical Co., Ltd. to commercialize the drug in China and with Kuhnil Pharmaceutical Co., Ltd. for marketing in South Korea.
The FDA approval for Consensi will put the company on a stronger footing to secure commercial partnerships for the U.S. and other territories, Kitov's CEO Isaac Israel said in a statement.
Kitov is facing an ongoing investigation by the Israeli Securities Authority regarding disclosures associated with the data monitoring committee managing Consensi's phase 3 trial data. The company is also facing several investor lawsuits resulting from the Israeli investigation.
After securing FDA approval for Consensi, the company will now focus on developing its cancer drug candidate NT219, said J. Paul Waymack, Kitov's chairman and chief medical officer.
