Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|September 9, 2020
PRAC Recommends Marketing Authorization of Ulipristal Acetate be Revoked
Author(s)Pharmaceutical Technology Editors
PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.
Advertisement
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued its recommendation to revoke the marketing authorization of 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids.
According to a Sept. 4, 2020 press release, PRAC has confirmed that ulipristal acetate can cause liver injury after considering all available evidence, including reported cases of serious liver injury. During the review, patient and healthcare professional representatives were also consulted.
As it has not been possible to identify patients that are more at risk of liver injury, including serious liver injury, that would enable the risk to be reduced of using the medicine, PRAC has concluded that 5-mg ulipristal acetate should not be marketed in the European Union. The use of the medicines had already been suspended while the review was being performed.
PRAC’s recommendation will now be forwarded to EMA’s Committee for Medicinal Products for Human Use (CHMP).
Source:
Advertisement
Related to this article
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.
FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.
Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.
Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
Advertisement
Advertisement