World's First Oral Pill Against Covid-19 ‘Molnupiravir’ Approved In UK: All You Need To Know

An interim analysis of a Phase 3 study showed that molnupiravir can reduce the risk of hospitalization or death by approximately 50% for patients with mild or moderate COVID-19.

The oral pill works by inhibiting the replication of the virus inside the body, Merck said,

The UK has become the first country in the world to approve Merck's molnupiravir -- the world's first oral antiviral medicine against Covid-19. The country's Medicines and Healthcare products Regulatory Agency approved molnupiravir on Thursday, following a rigorous review of its safety, quality and effectiveness.

Co-developed with Ridgeback Biotherapeutics, molnupiravir can halve the risk of hospitalisation or death for patients with mild or moderate Covid-19 infections. The oral pill works by inhibiting the replication of the virus inside the body, Merck said in a statement.

The company also informed that the pill will be marketed as LAGEVRIO in the UK. The US Food and Drug Administration (FDA) and the European Medicines Agency has not yet decided on the drug's emergency authorisation.

With its approval in the UK, Molnupiravir has become the first oral antiviral medicine for Covid-19.

Phase 3 study of molnupiravir shows positive results

The drug's emergency authorisation in the UK is based on positive results from an interim analysis of a Phase 3 study that included 775 participants. According to the study results, only 7.3 per cent of patients treated with molnupiravir were hospitalised within 29 days but no deaths were reported within the same period. Among placebo-treated patients, 14.1 per cent were hospitalised or eight deaths were reported within the 29-day period.

The company also claimed that molnupiravir demonstrated consistent efficacy against Covid-19 variants Gamma, Delta, and Mu, regardless of the timing of symptom onset or underlying risk factor.

At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50% for patients with mild or moderate COVID-19.

Developers optimistic about Molnupiravir's role in fight against COVID-19pandemic

"More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world. With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic," said Robert M. Davis, chief executive officer and president, Merck.

Wendy Holman, chief executive officer of Ridgeback Biotherapeutics, commented, "With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed."

Merck is targeting to produce 10 million courses of oral antiviral treatment by the end of 2021, with more doses expected to be produced in 2022.