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Modest meeting sees only two drugs recommended by CHMP

Lilly’s migraine med Emgality receives negative opinion for label extension


The European Medicines Agency’s advisory Committee for Medicinal Products for Human Use has recommended only one new drug and one generic medicine at its latest meeting, with a surprise negative opinion for Eli Lilly’s migraine med Emgality.

The CHMP recommended a marketing authorisation of Japanese pharma company Shionogi’s antimicrobial drug Fetcroja (cefiderocol) for the treatment of infections caused by Gram-negative organisms in adults with limited treatment options.

Shionogi’s drug was approved by the FDA last November for as a treatment for adults patient with complicated urinary tract infections (cUTI) who have limited or no alternative treatment options.

According to Shionogi’s executive vice president and director of the board Takuko Sawada, Fetcroja has a unique mechanism of cell entry, exploiting the bacteria’s own iron uptake transporters to effectively enter the bacterial cell”.

“This allows it to overcome the three major mechanisms of carbapenem-resistance in Gram-negative bacteria,” he added.

Approximately 25,000 patients die from an infection with selected multi-drug resistant bacteria in Europe each year.

The only other new medicine to receive a positive recommendation from the CHMP was Acccord Healthcare's generic Tigecycline, for the treatment of complicated skin and soft tissue infections and complicated intra-abdominal infections.

For Lilly, the meeting highlights were not so positive. The CHMP issued a negative opinion for the extended use of its migraine treatment Emgality as a preventative treatment in adults who suffer from episodic cluster headaches.

The refusal to extend the indication was based on concerns that results from the single study in patients with episodic cluster headache did not show a clear benefit in preventing attacks. As the CHMP aptly put it, "the benefits of Emgality (…) did not outweigh its risks”.

The FDA approved Emgality for use in this indication back in June last year, a win for Lilly that meant Emgality became the first CGRP inhibitor indicated for use in reducing cluster headaches.

The drug was third to market in the class, coming behind first place winner Aimovig (erenumab) from Amgen and second entrant Ajovy (fremanezumab) from Teva.

Also picking up label extensions were Takeda’s Alunbrug (brigatinib), Boehringer Ingelheim’s Ofev (nintedanib) and Amgen’s Otezla (apremilast).

Takeda also picked up a positive recommendation for a new subcutaneous formulation of its ulcerative colitis and Crohn’s med Entyvio (vedolizumab).

If approved, it will become the only maintenance therapy for these conditions with both intravenous and subcutaneous formulations in Europe.

The CHMP also noted the withdrawal of Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (iplimumab) application, which was seeking marketing authorisation in first-line metastatic non-small cell lung cancer.

BMS withdrew the marketing application after EU regulators presented major concerns abut the CheckMate-227 study which formed the basis of the submission.

Article by
Lucy Parsons

2nd March 2020

From: Regulatory



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