Akum Pharma gets CDSCO panel nod to manufacture, market antihypertensive FDC drug

However, this approval is subject to the condition that the Phase IV clinical trial be conducted. In accordance with this, the drug maker is directed to submit the Phase IV clinical trial protocol within 3 months from the date of approval.

This came after the firm presented the results of the bioequivalence (BE) study report of the hypertensive fixed-dose combination drug, Cilnidipine 20 mg plus Telmisartan IP 40 mg tablets, before the committee.

Cilnidipine is a calcium channel blocker. It aids in treating high blood pressure. Cilnidipine stops the calcium activity in the blood vessels and the heart. As a result, there is an increase in the supply of blood to the heart. This in turn helps lower blood pressure and slow the heart rate.

Cilnidipine acts on the L-type calcium channels of blood vessels by blocking the incoming calcium and suppressing the contraction of blood vessels, thereby reducing blood pressure. Cilnidipine also works on the N-type calcium channel located at the end of the sympathetic nerve, inhibiting the emission of norepinephrine and suppressing the increase in stress blood pressure.

Telmisartan is an angiotensin II receptor antagonist (ARB) used in the management of hypertension. Telmisartan interferes with the binding of angiotensin II to the angiotensin II AT1-receptor by binding reversibly and selectively to the receptors in vascular smooth muscle and the adrenal gland. As angiotensin II is a vasoconstrictor, which also stimulates the synthesis and release of aldosterone, blockage of its effects results in decreases in systemic vascular resistance. Telmisartan does not inhibit the angiotensin-converting enzyme, other hormone receptors, or ion channels.

At an earlier SEC meeting for Cardiovascular and Renal, in response to the drug maker Akum Pharma's proposal for a Phase III clinical trial waiver, the expert panel noted that the FDC of cilnidipine 10mg/10mg and telmisartan 40mg/80mg tablets is already approved by CDSCO for continued manufacturing and marketing.

In view of the above observation, the expert panel granted permission to conduct the proposed BE study, and accordingly, the firm was directed to present the results of the BE study for further consideration.

Now, in continuation, at the recent SEC meeting for Cardiovascular and Renal held on November 10, 2022, the expert panel reviewed the results of the BE study report of the hypertensive FDC drug Cilnidipine 20 mg plus Telmisartan IP 40 mg tablets.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the proposed FDC with the condition that a Phase IV clinical trial be conducted.

Accordingly, the firm is directed to submit the Phase IV clinical trial protocol within 3 months from the date of approval.