After vaccines, the fight against Coronavirus has reached the next level. The US Food and Drug Administration (FDA) has given Emergency Use Authorization (EUA) for the first oral antiviral treatment for Covid-19 - Pfizer's Paxlovid, a combination of two antivirals, nirmatrelvir and ritonavir.
Pfizer today said it is ready to start immediate delivery in the US, and will supply 10 million treatment courses between 2021 and 2022. The company, while raising the projections of Paxlovid production from 80 million to 120 million courses in 2022, added that it plans to file a New Drug Application (NDA) with the FDA for full regulatory approval.
Final results of Paxlovid's phase-3 clinical trials showed reduction of hospitalization or death by 89% within three days of symptom onset, and 88% within five days of symptom onset. Pfizer said it has submitted applications for regulatory approvals to multiple regulatory agencies and has initiated bilateral outreach to approximately 100 countries around the world.
The company has also signed a voluntary license agreement with the Medicines Patent Pool (MPP) so generic manufacturers can make the drug available in middle-income countries, which account for approximately 53% of the world’s population. It is investing over $1 billion to make the drug available globally. Industry sources say several Indian pharmaceutical manufacturers, which supply a lion's share of the generic drugs globally, are likely to benefit from licensing with Pfizer and MPP.
Analysts expect the pill to generate $10-15 billion in revenues. Pfizer is yet to reveal the price of the drug and says it will offer the oral antiviral therapy through a tiered pricing approach, based on the income level of each country to promote equity of access across the globe. High and upper-middle income countries will pay more than lower income countries.
US based Merck (known as MSD outside of the US and Canada) and Ridgeback Biotherapeutics also developed an oral pill for Covid-19, Molnupiravir, a re-purposed old molecule. But the latest data showed its efficacy at only 30%. Roche and its partner Atea Pharmaceuticals meanwhile terminated its plans for an oral antiviral pill a month ago due to poor results in the second phase trials.
Paxlovid is to be administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days once confirmed with the disease. One carton contains five blister packs. "This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
On December 16, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also cleared the drug to be used to treat adults with Covid-19, who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.