Novartis Clozaril blood monitoring frequency decrease after six months recommended by FDA committee.
CLOZARIL BIWEEKLY BLOOD TESTS WOULD LEAD TO .4 MORE AGRANULOCYTOSIS CASES per 1,000 patient-years after six months of therapy compared to the current weekly blood cell monitoring schedule, according to a registry analysis presented by Novartis to FDA's Psychopharmacologic Drugs Advisory Committee July 14. The committee unanimously recommended the less frequent blood sampling after six months and voted 7-3 to allow monitoring after one year of therapy to be voluntary. No recommendation was made for when to discontinue blood cell counts for the antipsychotic.
More from Archive
More from Pink Sheet
Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.