An experimental pill developed by Pfizer to treat COVID-19 can be used in European Union countries even though its full review is still pending, the bloc’s drug regulator said on Thursday.
“The medicine, which is not yet authorized in the EU, can 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,” read a statement by the European Medicines Agency (EMA).
The regulator said a rolling review of the pill, called Paxlovid, has been started.
It should be given to patients “as soon as possible after the diagnosis of COVID-19 and within 5 days of the start of symptoms.”
The EMA said its advice was for “national authorities who may decide on the possible early use of the medicine prior to marketing authorization, for example in emergency use settings, in the light of rising rates of infection and deaths due to COVID-19 across the EU.”
A study in “non-hospitalized, unvaccinated patients who had symptomatic disease and at least one underlying condition … showed that Paxlovid reduced the risk of hospitalization and death when treatment started within 5 days of the start of symptoms,” read the statement.
“About 1% of patients (6 out of 607) who took Paxlovid within five days of the start of symptoms were hospitalized within 28 days of starting treatment compared with 6.7% of patients (41 out of 612) given placebo (a dummy treatment); none of the patients in the Paxlovid group died compared with 10 patients in the placebo group,” the EMA said.
The most common side effects reported during treatment and up to 34 days after the last dose of Paxlovid were dysgeusia (taste disturbance), diarrhea and vomiting, the agency added.
Pfizer said this week that the pill appears to be effective against the new omicron variant, which has swept across the world since being first identified by scientists in South Africa in November.
The US firm said results of a study with around 2,250 people showed that the drug slashed hospitalizations and deaths by about 89% if taken shortly after initial COVID-19 symptoms.
Nod to 2 drugs
The EMA also recommended the authorization of two other COVID-19 pills.
It said monoclonal antibody medicine Xevudy, made by UK giant GlaxoSmithKline and US company Vir Biotechnology, “significantly reduces hospitalization and deaths in patients with at least one underlying condition putting them at risk of severe COVID-19.”
In a separate statement, the EU regulator said immunosuppressive medicine Kineret, developed by Swedish Orphan Biovitrum, has been found to “reduce the inflammation associated with COVID-19 and thus decrease lower airway damage, preventing development of severe respiratory failure.”/agencies
