FDA Approves AstraZeneca’s Covid Antibody Drug For Vulnerable Patients
The two-dose antibody drugs are the first intended for long-term prevention against covid infection, rather than a short-term treatment for people with compromised immune systems.
AP:
New COVID-19 Antibody Drug OK'd To Protect Most Vulnerable
Federal health officials on Wednesday authorized a new COVID-19 antibody drug for people with serious health problems or allergies who can’t get adequate protection from vaccination. Antibody drugs have been a standard treatment for treating COVID-19 infections for over a year. But the AstraZeneca antibody drug cleared by the Food and Drug Administration is different. It’s the first intended for long-term prevention against COVID-19 infection, rather than a short-term treatment. (Perrone, 12/8)
NBC News:
FDA Clears AstraZeneca Covid Antibody Treatment For Immunocompromised
To date, such laboratory-produced antibodies have been authorized only as early treatment of Covid-19 or as preventive therapy for high-risk people immediately after close contact with someone who has tested positive. Evusheld can be used as PrEP by people ages 12 and older who are moderately to severely immunocompromised and may not get adequate immune responses from a Covid vaccine. The therapy is also an option for the rare people who have histories of severe adverse reactions to a Covid vaccine or its components. (Ryan, 12/8)
Also —
FiercePharma:
Gilead Recalls 2 Lots Of COVID-19 Drug Veklury After Finding Glass Particulates In Vials
Gilead Sciences' surprise blockbuster Veklury has braved its share of efficacy critiques. Now, the drug has run up against a manufacturing glitch. Gilead is recalling two lots of the COVID-19 antiviral Veklury, also known as remdesivir, after a customer complaint flagged the presence of glass particulates. Gilead confirmed the complaint through its own investigation, the company said Friday. (Kansteiner, 12/6)
CNBC:
Pfizer Will Submit Full Data On Covid Treatment Pill To FDA In A Few Days: CEO
Pfizer will submit full data on its Covid treatment pill to the Food and Drug Administration in the coming days, CEO Albert Bourla told CNBC on Wednesday. Bourla said he’s confident the full results from the clinical trials will show that the oral antiviral pill, Paxlovid, reduces Covid hospitalization and death by 89% as interim data showed in November. Paxlovid is taken in combination with a popular HIV drug, ritonavir. (Kimball, 12/8)
