Biophore applies to DCGI for emergency-use approval for COVID-19 treatment drug

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The company plans to commence commercial production of the product immediately after the approval is received, the Hyderabad-based firm said.

Biophore India Pharmaceuticals on Friday said it has applied to the Drugs Controller General of India (DCGI) for obtaining emergency-use approval for Aviptadil, used in the treatment of moderate to severe cases of COVID-19.

The Hyderabad-based firm said it has developed the product which is backward integrated with its in-house Active Pharmaceutical Ingredient (API).

The company plans to commence commercial production of the product immediately after the approval is received, it added.

Aviptadil is a synthetic form of Vasoactive Intestinal Peptide (VIP) that, when administered, results in rapid clinical recovery in patients with severe SARS-COV-2 infection.

These observations are based on results of multiple trials of Aviptadil against COVID-19 globally in patients with respiratory failure and the same have been submitted to DCGI for their review.

“The company has developed this highly complex peptide in a very short period of time, primarily due to the extensive focus of the company in prioritising COVID related products over the last one year,” Biophore CEO Jagadeesh Babu Rangisetty said in a statement.

Aviptadil is a very promising treatment option for COVID-19, especially in severe hospitalised cases where trials have shown a high recovery percentage, he added.

“We hope to be able to quickly make it available through this approval,” Mr. Rangisetty noted.

Biophore was one of the first few manufacturers to have received approval for an antiviral agent, Favipiravir, in the country during the first wave of COVID-19 and is also the only Indian manufacturer to be producing multi-tonnage volumes of Sulfobutyl Ether beta Cyclodextrin (SBECD), which is a key excipient in the manufacturing of Remdesivir injections.

Apart from these, the company said it has invested significantly into the research and development of other anti-COVID-19 products over the last one year.

“While we are optimistic that the pandemic will end soon, we have to be prepared for the exigencies. We need to keep evaluating and adding newer products against this virus to ensure better preparedness by having more options for the treating physicians and thus avoiding shortages. Our aim is also to make the cost of treatment affordable, especially for hospitalised patients,” Mr. Rangisetty said.

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