Industry

India may have to wait longer for Pfizer, GSK's Covid drugs


There is uncertainty over the availability in India of ‘s antiviral drug Paxlovid and GSK‘s monoclonal antibody Sotrovimab (sold under the brand name Xevudy) – two therapies that appear to be effective against the Omicron variant, as both companies are yet to apply for emergency use approval. Both drugs have been approved in the US, Europe, UK and other countries.

“Nothing firmed up as yet. We are discussing options with the global team,” GSK India spokesperson told ET, referring to Xevudy. Pfizer said it is firmly committed to supporting India in its fight against the pandemic.

“We continue our engagement with the government of India to bring our vaccine and anti-viral therapy to the country,” said Pfizer spokesperson. “Globally, Pfizer has entered into advance purchase agreements with multiple countries and is in discussions with several others to bring its Covid-19 anti-viral treatment for use within the required populations,” the spokesperson added.

Last month Pfizer had announced an agreement with the UN‘s Medicines Patent Pool (MPP) for licensing antiviral intellectual property to MPP with the goal of making the drug available in low and middle-income countries.

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The terms of the pact allow MPP to sub-license qualified generic medicine manufacturers worldwide, who will supply to countries covered by the agreement as well as to countries where there are no patents. The agreement covers 95 low and lower-middle-income countries, including India. Several Indian companies are in the process of applying for manufacturing licences with MPP.

How long the licensing process could take is still not clear. As per regulatory requirements, companies will have to conduct a bridging trial in India to get approval, though the Indian drug regulator may grant a waiver on a case-to-case basis depending on the urgency of the situation and if India is part of a global phase-3 trial.

Both Pfizer’s antiviral pill and GSK’s monoclonal antibody worked in laboratory studies against the Omicron variant. Paxlovid and Sotrovimab, along with Molnupiravir from Merck are seen to be Covid-specific therapies that work against both the Omicron and Delta variants.

India this week approved Molnupiravir for emergency use for high-risk population and the drug is expected to be available in the market next week. Monoclonal antibody cocktails such as casirivimab-imdevimab developed by Regeneron and Roche, and bamlanivimab-etesevimab by Eli Lily emerged towards the last phase of the second wave.



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