Kitov (KTOV) Gets Approval From FDA For Consensi, Shares Up

Kitov Pharma Ltd. (NASDAQ:KTOV) announced today that the FDA has approved Consensi (amlodipine and celecoxib) oral tablets for the treatment of osteoarthritis pain and hypertension.

The drug is a combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID), and amlodipine besylate, an antihypertensive calcium channel blocker that has been approved for once daily use in three dosage forms, corresponding to the current approved dosages of amlodipine (2.5, 5, and 10 mg) for the treatment of hypertension and a 200 mg dose of celecoxib for osteoarthritis pain.

The FDA’s approval was based on positive results from the phase III trial that met its primary endpoint. According to the study, the drug lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients treated with amlodipine besylate only with statistical significance of p=0.001.

It has been approved for patients who are appropriate for treatment with amlodipine for hypertension and celecoxib for osteoarthritis.

Shares of the company gained 40% on the news. Kitov Pharma’s stock has gained 6.9% in the last six months as against the industry’s gain of 5.2%.

The company will now focus on the development of NT219, which is currently in development for various oncology indications.

However, Consensi is expected to face competition in the oral anti-arthritic market from traditional non-selective NSAIDs (such as naproxen and ibuprofen), traditional NSAID/gastroprotective agent combination products and combination product packages such as Horizon Pharma’s (NASDAQ:HZNP) Vimovo among others. The company also faces competition from Pfizer’s (NYSE:PFE) Celebrex.

Zacks Rank

Kitov Pharma carries a Zacks Rank #3 (Hold). A better ranked player in the healthcare sector is Ligand Pharmaceuticals (NASDAQ:LGND) which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here..

Ligand’s earnings per share estimates increased from $4.09 to $4.37 per share in the last 30 days. The company delivered a positive earnings surprise in all the trailing four quarters, with an average beat of 31.79%.

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