Pfizer asks U.S. regulators FDA for authorisation on its experimental COVID-19 pill. Putting themselves into a position for a likely launch of the promising therapy. The company’s filing comes as new infections are rising once again.
It is one of a handful of pills that have reduced the risk of hospitalisation and death. If authorised by the FDA it could be a giant leap toward managing the pandemic. It will mean that patients will be able to treat themselves at home.
“We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients, and we look forward to working with the U.S. FDA on its review of our application,” said Albert Bourla, Pfizer’s CEO, in a statement.
All FDA authorised treatments against COVID-19 require an IV or injection given by a health professional at a hospital or clinic.
FDA regulators will pore over the company data on the safety and effectiveness of the experimental COVID-19 pill. The drug is to be sold under the name of Paxlovid
The FDA is holding a public meeting later this month where outside experts will scrutinise a competing COVID-19 pill from Merck, before voting on whether to recommend approval. The FDA isn’t required to convene such meetings and it’s not yet known whether Pfizer’s drug will undergo a similar public review.
Some experts predict various COVID-19 therapies eventually will be prescribed in combination to better protect against the worst effects of the virus.
Several smaller drugmakers are also expected to seek authorization for their own antiviral pills in the coming months.
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