Glenmark set to get manufacturing and marketing approval for favipiravir

Sources inform that SEC has recommended the grant of permission, along with some recommendations, the company plans to launch its product early next week

Under accelerated approval process at the Central Drugs Standard Control Organisation (CDSCO), the Subject Expert Committee (SEC) of the COVID-19 has recommended the grant of permission to manufacture and market Glenmark Pharmaceuticals’ phase III clinical trial drug, Favipiravir, 200 mg tablet. It is assumed that the company will launch the product in the market by early next week.

However, before the launch of the drug, the committee has also asked the company to submit a copy of the informed consent form to the CDSCO and recommended it to present the complete report of the ongoing clinical trial within three months.

Since favipiravir is contraindicated in patients with severe renal and hepatic impairment, pregnant and lactating women, the subject expert committee of COVID-19 has also recommended that the drug should be used with caution in patients with a history of abnormalities in metabolism of uric acid or having gout. It also mentioned that active post-marketing surveillance should be conducted on the first 1000 patients to access safety as well as efficacy.

A source from Glenmark informed, “We are waiting for the formal communication from the DCGI office. However, with some recommendations, we have received verbal intimation about the permission granted for the manufacturing and marketing of our favipiravir 200 mg tablet.”

He also updated that the company has already geared up for the launch of the product from its manufacturing facility located in Himachal Pradesh. And, the company has already started booking bulk orders from corporate hospitals and stockists, except government institutions.

Favipiravir, one of the potential drug candidates for the treatment of coronavirus (COVID-19) infections, is presently undergoing clinical trials for COVID-19 in various countries such as China, Japan, the US, Russia, Italy and South Korea. Glenmark had initiated clinical trials after it received permission from the DCGI in May 2020.

Glenmark Pharmaceuticals has submitted a proposal to the DCGI for approval of favipiravir 200 mg tablets for emergency use authorisation (EUA) along with various supporting documents, including clinical data and interim analysis data of the clinical trial ongoing in the country. If approved, Glenmark’s favipiravir will require a total of 122 tablets for 14 days of treatment. Reportedly,  every strip will contain 34 tablets of 200 mg with an approximate MRP of Rs 3500.

In response to the query whether Maharashtra plans to procure favipiravir for COVID-19 treatment, Dr Sanjay Oak, Head of Maharashtra State Task Force and former Director of KEM hospital, Mumbai informed, “We have given the recommendation about the use of favipiravir drug for COVID-19 treatment to the government and mentioned it in the Maharashtra COVID-19 task force as well. However, the decision to procure it is up to state government health authorities.”

Rajesh Tope, the Maharashtra Health Minister did not revert on the query about procurement of favipiravir till the time, the story was filed.