Biophore applies for DCGI emergency use approval of Aviptadil for Covid-19
- Aviptadil has shown significant results in clinical trials against Covid-19
- Biophore has developed both the API and the formulation in-house
- Approval sought for the emergency use for the treatment of moderate to severe cases of Covid-19
Hyderabad: A Hyderabad-based Biophore India Pharmaceuticals has applied for Drugs Controller General of India (DCGI) emergency use approval of Aviptadil Inhalation for marketing in India for the treatment of moderate to severe cases of Covid-19.
Dr Jagadeesh Babu Rangisetty, CEO at Biophore said, "Aviptadil has been successfully developed and it is 'backward integrated with in-house API'. The company will be commencing commercial production immediately after the approval is received. Giving details of Aviptadil, it 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 has been submitted to DCGI for their review."
"Biophore has developed this highly complex peptide in a very short period of time, primarily due to the extensive focus of the company in prioritizing Covid related products over the last one year. Aviptadil is a very promising treatment option for Covid, especially in severe hospitalized cases where trials have shown a high recovery percentage and we hope to be able to quickly make it available through this approval" he added.
Dr Jagadeesh Babu stated Biophore has been actively involved in developing products against Covid-19 and scaling up manufacturing to meet the requirements. The company was one of the first few manufacturers to have received approval for an anti-viral agent, Favipiravir, in India during the first wave 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, Biophore has invested significantly into the research and development of other anti-Covid products over the last year.
Further, expressing a hope of optimism that the pandemic will end soon, he however said that "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 hospitalized patients."