FDA Confirms Paragraph IV Patent Litigation for Baricitinib Tablets
Eli Lilly’s alopecia areata drug is off to a good start with dermatologists. So good, in fact, that the launch of Olumiant in alopecia looks a lot like the initial positive launch of Sanofi and Regeneron’s Dupixent, according to launch tracking data from Spherix Global Insights.
Advisers to the European Medicines Agency on Friday recommended limiting the use of a group of widely prescribed inflammatory disease drugs due to safety concerns, following a similar, but more restrictive ruling last year by regulators in the U.S.
Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
Following the US’ lead, the EMA is cutting back on the use of JAK inhibitors for some patients over a suite of safety concerns.
The FDA is changing up its marketing rules for emergency use Covid treatments. Six drugmakers can now more broadly promote their Covid therapies, including Pfizer’s Paxlovid and AstraZeneca’s Evusheld.
Eli Lilly has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for baricitinib – also known as Olumiant – for the treatment of severe alopecia areata in adult patients.
Trio of therapies reduces risk of death in patients with severe COVID-19
FDA Confirms Para IV Patent Litigation for Baricitinib tablets.
Eli Lilly’s commitment to the immunology field has paid off with another important approval for JAK inhibitor Olumiant. And it's an industry first in alopecia areata.