Biophore applies to DCGI for emergency-use approval for Covid treatment drug Aviptadil – About Your Online Magazine


Biophore India Pharmaceuticals said on Friday that it has asked the Comptroller General of Medicines of India (DCGI) to approve the emergency use of Aviptadil, which is used to treat moderate to severe cases of Covid-19.

The Hyderabad-based company said it has developed the product that is retroactively integrated with its internal API (active pharmaceutical ingredient).

The company plans to start commercial production of the product immediately after receiving approval, he added. Coronavirus Updates on June 11

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 from multiple trials of Aviptadil versus COVID-19 globally in patients with respiratory failure and these were submitted to the DCGI for review.

“The company developed this highly complex peptide in a very short period of time, primarily due to the company’s broad focus on prioritizing COVID-related products over the past year,” said Jagadeesh Babu Rangisetty, CEO of Biophore, in a statement.

Aviptadil is a very promising treatment option for COVID, especially in severe cases of hospitalization, where studies have shown a high percentage of recovery, he added.

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

Biophore was one of the first manufacturers to receive approval for an antiviral agent, Favipiravir, in the country during the first wave of COVID-19 and is also the only Indian manufacturer to produce multiple tonnage volumes of sulfobutyl beta cyclodextrin (SBECD ) ether. which is a key excipient in the manufacture of Remdesivir Injections.

In addition, the company said it has invested significantly in research and development of other anti-COVID products over the past year.

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

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Paula Fonseca