EMA’s human medicines committee (CHMP) recommended four medicines for approval at its May 2019 meeting.

The Committee recommended granting a marketing authorisation for Cufence (trientine dihydrochloride), for the treatment of Wilson’s disease, a rare inherited disorder that causes copper to accumulate in the liver, brain and other vital organs. Cufence was designated as an orphan medicine during its development.

The CHMP granted a positive opinion for LysaKare (Arginine/lysine) for protecting the kidneys against radiation during radioactive therapy with lutetium (177Lu) oxodotreotide.

Two generic medicines intended for the treatment and prevention of fungal infections received a positive opinion from the Committee: Posaconazole Accord (posaconazole) and Posaconazole AHCL(posaconazole).

Negative opinion on a new medicine

The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Xyndari(glutamine). Xyndari was expected to be used to treat sickle cell disease, an inherited form of anemia. For more information please see the question-and-answer document in the grid below.

Negative recommendation on new medicine following re-examination

The applicant for Doxolipad (doxorubicin) requested a re-examination of the Committee’s negative opinion adopted at the January 2019 meeting. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine, which was intended for the treatment of breast and ovarian cancer.

Start of referral

The CHMP started a review of the effectiveness of medicines containing a combination of methocarbamol and paracetamol for the treatment of painful muscle spasms. The review is being carried out at the request of the German medicines agency, BfArM.

Withdrawals of applications

Applications for initial marketing authorisations for Ambrisentan Zentiva (ambrisentan) and Radicava (edaravone) have been withdrawn.

Ambrisentan Zentiva was intended for the treatment of pulmonary arterial hypertension (high blood pressure in the arteries of the lungs).

Radicava was intended for the treatment of amyotrophic lateral sclerosis, a rare disease of the nervous system, where nerve cells in the brain and spinal cord that control voluntary movement gradually deteriorate, causing loss of muscle function and paralysis.

Posted on the EMA website on 29 May 2019