Kitov’s combo gets FDA approval in osteoarthritis and hypertension
pharmafile | June 1, 2018 | News story | Medical Communications, Sales and Marketing | Consensi, FDA, Kitov, US, hypertension, osteoarthritis, pharma
Israeli biopharmaceutical firm is celebrating the approval in the US of Consensi, a combo of the calcium channel blocker amlodipine and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, after the FDA authorised the drug for the treatment of osteoarthritis and hypertension.
The approval came off the back of Phase 3 results which demonstrated that Consensi was able to lower patients’ daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved with amlodipine besylate alone. In addition to this, use of the drug produced a statically significant reduction in serum creatine, a key marker of improved renal function, compared to placebo or amlodipine alone.
The authorisation covers three levels of dosage in the treatment of hypertension, corresponding to currently approved dosages of amlodipine: 2.5mg, 5mg and 10mg. It also covers a 200mg dose of celecoxib for osteoarthritis.
“Over 50 million Americans suffer from osteoarthritis. About one of three US adults or about 75 million people have high blood pressure, known as the “silent killer” due to the absence of noticeable symptoms,” explained Kitov CEO Isaac Israel. “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.
“We recently expanded our commercialization network for Consensi by securing a second licensing agreement in Asia with a major Chinese pharmaceutical company. The FDA approval of Consensi puts us in a stronger position towards securing commercial partnerships for the US and other key territories,” he added.
Matt Fellows
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