CHMP recommends thirteen medicines for approval

CHMP recommends thirteen medicines for approvals
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended thirteen medicines for approval.

The Committee recommended granting marketing authorisations for two cancer medicines: Zejula – an orphan designated medicine intended for the treatment of ovarian cancer – and Tookad, for the treatment of adenocarcinoma of the prostate.

Also included among this latest round of recommendations are Elebrato Ellipta and Trelegy Ellipta, two medicines for the treatment of adults with moderate to severe chronic obstructive pulmonary disease.

A further two medicines were given positive opinion for people using opioids in Nyxoid, intended for the treatment of opioid overdose, and Zubsolv intended for the treatment of opioid dependence.

The CHMP also adopted a positive opinion for Tremfya for the treatment of plaque psoriasis.

VeraSeal received a positive opinion for use as a sealant during surgical operations in adults.

Two biosimilar medicines were recommended for approval in Cyltezo – for the treatment of rheumatoid arthritis, psoriasis and Crohn’s disease among others – and Ontruzant for the treatment of early and metastatic breast cancer, and metastatic gastric cancer.

Ontruzant is the first trastuzumab biosimilar recommended for approval by the CHMP.

Three generic medicines received a positive opinion from the CHMP – Imatinib Teva B.V. for the treatment of leukaemia and gastrointestinal stromal tumours; Miglustat Gen.Orph for the treatment of mild to moderate type 1 Gaucher disease, and Ritonavir Mylan for the treatment of HIV infection.