EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its November 2019 meeting

  • Posted on: 18 November 2019
  • By: Shalini.Sharma

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The Committee recommended granting a marketing authorisation for Isturisa* (osilodrostat) for the treatment of Cushing’s syndrome, a rare disorder that occurs when the body produces too much corticosteroid hormone. It leads to patients experiencing weight gain, fat build-up on the face and bruising.

Mayzent (siponimod) received a positive opinion for the treatment of adult patients with secondary progressive multiple sclerosis with active disease evidenced by relapses or imaging features of inflammatory activity.

The Committee recommended granting a conditional marketing authorisation for Polivy* (polatuzumab vedotin) for the treatment of relapsed/refractory diffuse large B-cell lymphoma, a rare type of cancer of the white blood cells.

The CHMP adopted a positive opinion for Sunosi (solriamfetol), for the treatment of excessive daytime sleepiness in patients with narcolepsy (a sleep disorder that causes a person to fall asleep suddenly and unexpectedly) and obstructive sleep apnoea (interruption of breathing).

Tavlesse (fostamatinib) received a positive opinion from the CHMP for the treatment of primary immune thrombocytopenia. This is an acquired immune-mediated disorder characterised by the destruction of platelets and impaired platelet production.

The CHMP recommended granting marketing authorisations for two generic medicines: Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel / acetylsalicylic acid), for the secondary prevention of atherothrombotic events (problems caused by blood clots and hardening of the arteries); and Deferasirox Accord (deferasirox), for the treatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia and other anaemias.

The applicant for Hopveus (sodium oxybate) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the October 2019 meeting. The CHMP will re-examine the opinion and issue a final recommendation. For more information on this negative opinion, please see the question-and-answer document in the grid below.

The Committee recommended extensions of indication for Kadcyla and Revlimid.

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