EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its November 2019 meeting.
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. Polivy was supported through EMA’s PRIority MEdicines (PRIME) scheme.
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.
Start of re-examination of recommendation for new medicine
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.
Two recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Kadcyla and Revlimid.
Outcome of review on Lemtrada
The Committee recommended restricting the use of the multiple sclerosis medicine Lemtrada (alemtuzumab) due to reports of rare but serious side effects, including deaths. New measures to identify and manage the serious side effects are also recommended. The side effects include cardiovascular disorders (affecting the heart, circulation and bleeding as well as stroke) and immune-related disorders (caused by the body’s defence system not working properly).
Outcome of review on Xeljanz
The CHMP concluded that Xeljanz (tofacitinib) could increase the risk of blood clots in the lungs and in deep veins in patients who are already at high risk. As a result, the Committee recommended that Xeljanz should be used with caution in all patients at high risk of blood clots. In addition, the maintenance doses of 10 mg twice daily should not be used in patients with ulcerative colitis who are at high risk of blood clots unless there is no suitable alternative treatment. Due to an increased risk of infections, patients older than 65 years of age should be treated with Xeljanz only when there is no alternative treatment.
Withdrawals of applications
Applications for initial marketing authorisations for Linhaliq (ciprofloxacin) and Luxceptar (viable T-cells) have been withdrawn. Linhaliq was intended for the treatment and prevention of flare-ups of non-cystic fibrosis bronchiectasis in patients with long-term lung infection caused by Pseudomonas aeruginosa bacteria. Luxceptar was intended for the treatment of patients with blood cancers who are receiving a type of blood stem cell transplant.
The application to extend the use of Opsumit (macitentan) to treat chronic thromboembolic pulmonary hypertension, a condition that causes high blood pressure in the lungs, was also withdrawn.