CHMP recommends just two new meds in Feb meeting

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended just two new medicines for approval at its February 2020 meeting, as well as three extensions of pre-existing therapies.

First up, the committee recommended granting a marketing authorisation for Shionogi’s Fetcroja (cefiderocol) - a drug indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

A Shionogi spokesperson commented on the decision, saying: "Fetcroja is the first treatment which provides coverage against all Gram-negative pathogens considered of critical priority by the World Health Organisation – carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacterales."

The other recommended medicine was Tigecycline Accord (tigecycline), a generic med from Accord Healthcare for the treatment of complicated skin and soft tissue (i.e. tissues just below the skin) infections and complicated intra-abdominal infections.

On top of the recommendations, the decision makers also recommended extensions of indication for Takeda’s Alunbrig (brigatinib), Boehringer Ingelheim’s Ofev (nintedanib) and Otezla (apremilast) from Amgen.

The organisation also recommended the addition of a new pharmaceutical form for Takeda's Entyvio (vedolizumab): a 108 mg solution for injection to be given subcutaneously.

Takeda says that the decision, which was based on the pivotal Phase III VISIBLE trials, brings the treatment "one step closer to becoming the only maintenance therapy with both intravenous and subcutaneous formulation options for patients with ulcerative colitis or Crohn’s disease", providing greater options for how patients receive their treatment.

Unfortunately, the committee also revealed that it gave a negative opinion for an extension of indication for Eli Lilly’s preventative migraine drug Emgality (galcanezumab), to add prevention of attacks in adults who suffer from episodic cluster headache.

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