The CHMP Stiil Has Issues Over Filings For Tagraxofusp And Selinexor
• By Maureen Kenny
A number of companies with marketing applications at the later stages of the EU review process are seeking extra time to address remaining concerns the European Medicines Agency’s drug evaluation committee, the CHMP, has about their filings.
Time matters for companies seeking new product approvals • Source: Shutterstock
Two of the products whose sponsors are seeking extra time to respond to concerns the European Medicines Agency has regarding their late-stage marketing authorization applications (MAAs) were originally being fast-tracked through the review system.
ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.