India’s Sun Pharma forearming to produce Molxvir, a generic variation of Merck’s Molnupiravir

INDIA – Sun Pharmaceutical Industries, a leading pharmaceutical manufacturer in India, is gearing up to introduce Merck Sharpe Dohme and Ridgeback’s molnupiravir under the brand name Molxvir.

The Drugs Controller General of India (DCGI) is currently reviewing clinical data of molnupiravir for the treatment of COVID-19 in adults in India.

Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID-19 in adults. It is under review by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).

In the Phase 3 trial by Merck, Molnupiravir significantly reduced the risk of hospitalization or death by approximately 50 per cent in a planned interim analysis of the MOVE-OUT trial in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19.

Additionally, based on the participants with available viral sequencing data (approximately 40 per cent of participants), molnupiravir demonstrated consistent efficacy across viral variants like Gamma, Delta, and Mu Molxvir is a registered trademark of Sun Pharma.

However, Mercks antiviral pill is expected to face competition from Pfizer’s new drug, Paxlovid. Not too long ago, the Covid-19 vaccine giant announced that its antiviral Covid-19 treatment cut the chance of ending up in hospital or dying by 89 per cent.

Paxlovid is one potential COVID drug for use at home. The idea is these could be prescribed at the first sign of infection to prevent serious illness and death. People would manage their own symptoms, monitored while at home, and only be transferred to hospital if their condition deteriorates.

According to Pfizer’s trial results, Paxlovid could be used as an alternative to in-hospital treatment for preventing disease progression in patients with the same risk factors.

Adding to the portfolio of Covid-19 drugs, there is AstraZeneca’s emerging COVID drug Evusheld. The TGA has just given this “provisional determination”, meaning the company can now submit data for evaluation.

Evusheld contains two long-acting monoclonal antibody drugs – tixagevimab and cilgavimab. It’s an injection that could be given in hospital or as an outpatient to prevent infections from getting worse.

Human trials have shown when Evusheld was used before exposure to COVID, there were significantly fewer symptoms.

Although Evusheld may potentially be used to prevent COVID, it would not be a substitute for vaccination. But it could provide additional protection for people who may have an inadequate response to vaccination or who cannot be immunized.

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