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

The Committee recommended granting a marketing authorisation for Sixmo (buprenorphine) as a substitution treatment for opioid dependence. Sixmo is an implant that releases low levels of buprenorphine into the patient’s body for six months.

Two orphan medicines received a positive opinion from the CHMPEsperoct (turoctocog alfa pegol), for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency), and Ultomiris (ravulizumab), for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

Doptelet (avatrombopag) received a positive opinion for the treatment of severe thrombocytopenia.

The Committee adopted a positive opinion for Dovato (dolutegravir / lamivudine), for the treatment of HIV infection.

The CHMP recommended the granting of a conditional marketing authorisation for Libtayo (cemiplimab), for the treatment of advanced cutaneous squamous cell carcinoma.

The Committee adopted a positive opinion for Nuceiva (botulinum toxin type a), intended for temporary improvement of vertical lines between the eyebrows, when the severity of the facial lines has an important psychological impact in adults below 65 years of age.

Talzenna (talazoparib) received a positive opinion for the treatment of adult patients with germline BRCA1/2 mutations who have HER2-negative locally advanced or metastatic breast cancer.

The biosimilar medicine Grasustek (pegfilgrastim) received a positive opinion for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy.

The CHMP recommended granting marketing authorisations for two generic medicinesAmbrisentan Mylan(ambrisentan), for the treatment of pulmonary arterial hypertension, and Striascan (ioflupane (123I)), a radiopharmaceutical intended for the diagnosis of Parkinson’s disease and other related diseases and dementia.

The Committee granted a positive opinion for Xromi (hydroxycarbamide), a hybrid medicine for the prevention of vaso-occlusive complications of sickle cell disease in patients over 2 years of age. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

Temybric Ellipta (fluticasone furoate / umeclidinium / vilanterol), an informed consent application for the maintenance treatment of adults patients with moderate to severe chronic obstructive pulmonary disease, received a positive opinion from the CHMP. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Negative opinion on a new medicine

The CHMP adopted a negative opinion refusing a marketing authorisation for Cabazitaxel Teva (cabazitaxel). Developed as a hybrid medicine, Cabazitaxel Teva was expected to be used to treat prostate cancer.

One recommendation on extension of therapeutic indication

The Committee recommended an extension of indication for Lynparza.

Revocation of marketing authorisation for Lartruvo

The CHMP completed its assessment of the results of the ANNOUNCE study and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. Therefore, the Committee recommended that the conditional marketing authorisation of the medicine be revoked.

Update on nitrosamine impurities

Following an EU safety review, which concluded on strict legally binding limits for nitrosamine impurities in sartan blood pressure medicines, EMA continues to work closely with national authorities and international partners to ensure manufacturers are taking appropriate measures to avoid or keep presence of nitrosamine below the acceptable limits. Based on experience from the review of sartans, EMA is launching an exercise with experts from across the EU regulatory network to consider how to prevent such incidents in future and to see if their management can be improved, should they occur. EMA will publish the outcome of the exercise in due course.

As part of strengthened monitoring of manufacturing, EMA and national authorities are also requesting as precaution that companies using certain reagents to manufacture the diabetes medicine pioglitazone test their products and check their processes to rule out the presence of nitrosamine impurities, in particular nitrosodimethylamine (NDMA). The request follows the detection of low levels of NDMA in a few batches of pioglitazone manufactured by Hetero Labs in India.

Update on prescribing information for Tyverb

EMA is updating the prescribing information for Tyverb (lapatinib) following detection of errors in results of a study involving postmenopausal women who had ‘HR+/HER2+’ breast cancer and whose disease had worsened despite previous treatment with trastuzumab. The results had indicated a benefit of Tyverb over trastuzumab when each medicine was used together with an aromatase inhibitor.

Posted on the EMA website on 26 April 2019