FDA Approves Combo Drug for OA, Hypertension

The US Food and Drug Administration (FDA) has approved Kitov’s once-daily Consensi (amlodipine and celecoxib) oral tablets for the treatment of osteoarthritis (OA) pain and hypertension.

“Over 50 million Americans suffer from osteoarthritis,” said Dr J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer. “About 1 of 3 US adults or about 75 million people have high blood pressure ... As a result, patients’ adherence to the hypertension treatment regimen is low. We believe that Consensi, as a single pill combination treatment for osteoarthritis and hypertension, presents a unique value proposition of potentially increasing treatment adherence.”

Consensi was approved following the success of a Phase 3 clinical trial, during which Consensi was shown to reduce daytime systolic blood pressure by at least 50% compared with patients who were treated with amlodipine besylate alone.

The results of this trial were subsequently validated in another Phase 3/4 trial of Consensi.

In addition, in the Phase 3/4 trial, Consensi use was associated with a statistically significant reduction in serum creatinine, thus demonstrating improved renal function in Consensi-treated patients compared with placebo-treated patients.

Consensi is available in 3 doses: 2.5 mg, 5 mg, and 10 mg amlodipine for hypertension, in combination with 200 mg celecoxib for OA pain.

—Christina Vogt

Reference:

FDA approves Kitov’s Consensi™ for treatment of osteoarthritis pain and hypertension [press release]. Tel Aviv, Israel. Kitov Pharma Ltd. May 31, 2018. https://globenewswire.com/news-release/2018/05/31/1515108/0/en/FDA-Approves-Kitov-s-Consensi-for-Treatment-of-Osteoarthritis-Pain-and-Hypertension.html Accessed on June 4, 2018.