STAT+: Pharmalittle: EMA urges revoking authorization for Novartis sickle cell drug; U.K. tries to placate pharma execs
The European Medicines Agency recommended revoking marketing authorization for a Novartis sickle cell disease drug called Adakveo.
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we hope to check in on the Pharmalot ancestors, hang with our shortest person, promenade with the official mascot, and squeeze in a listening party — the rotation will include this, this, this and this. And what about you? This is a lovely time of year to enjoy the great outdoors, so perhaps you can head to a beach, lake, or the countryside to gaze at nature and lets the neurons relax. You could catch up on your reading. Or use this as an opportunity to catch up with someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you Tuesday, since there is an extended holiday on this side of the pond. …
The European Medicines Agency recommended revoking marketing authorization for a Novartis sickle cell disease drug called Adakveo. The move came after the EMA’s human medicines committee reviewed a study and concluded the benefits of the drug did not outweigh risks. The review found the drug did not reduce the number of painful crises leading to a health care visit. Patients treated with Adakveo had on average 2.5 painful crises with a subsequent health care visit over the first year of treatment, compared with 2.3 crises in the placebo group. And the average number of crises requiring a health care visit or treatment at home was 4.7 with Adakveo compared with 3.9 with placebo.
The U.S. Food and Drug Administration granted full approval to Paxlovid, the Pfizer Covid-19 pill, clearing the way for the company to sell the drug at market rates once U.S. government supplies dwindle, Reuters writes. The full approval for treating adults at high risk of progression to severe disease will help Pfizer expand its marketing campaign. U.S. officials plan to work through much of the government’s Paxlovid inventory, which is available for free at pharmacies around the country, before moving to a normal commercial market for the drug. Pfizer has sold the U.S. government nearly 24 million courses at around $530 a course, but it is not clear yet what price the company will charge.
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