Three new medicines recommended for approval

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

The Committee recommended granting a marketing authorisation for Giapreza (angiotensin II), for the treatment of refractory hypotension in adults with septic or other distributive shock.

Two informed consent applications received a positive opinion from the CHMPAzacitidine Celgene (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukemia; and Lacosamide UCB (lacosamide), for the treatment of partial-onset seizures with or without secondary generalisation. 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 recommending the refusal of a marketing authorisation for Evenity (romosozumab). Evenity was expected to be used to treat osteoporosis. For more information, please see the question-and-answer document in the grid below.

Start of re-examination of recommendation for new medicine

The applicant for Xyndari (glutamine) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at the May 2019 meeting. The CHMP will now 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.

New paediatric indication for type 2 diabetes medicine

The CHMP recommended an extension of indication for Victoza (liraglutide) to include the treatment of children and adolescents aged ten years or older with type 2 diabetes. For more information, please see the press release in the grid below.

Other extensions of indication recommended by the Committee were for CyramzaDupixentEbymectEdistrideFiaspFlebogamma DIFForxigaImbruvicaTecentriqXigduo and Zinforo.

Negative opinions on extension of therapeutic indication

The CHMP adopted a negative opinion for an extension of therapeutic indication for Revolade (eltrombopag) to add the treatment of previously untreated patients with severe aplastic anaemia from two years of age.

The Committee also adopted a negative opinion for an extension of the therapeutic indication of Translarna(ataluren) to add the treatment of patients with Duchenne muscular dystrophy who are no longer able to walk.

For more information on these negative opinions, please see the question-and-answer documents in the grid below.

Outcome of review on bacterial lysate medicines for respiratory conditions

The CHMP recommended that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia. This follows a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not be used for these purposes. For more information, please see the public health recommendation in the grid below.

Withdrawal of application

The application for an initial marketing authorisation for ABP 710 (infliximab) was withdrawn. This medicine was intended for treatment of some inflammatory diseases. A question-and-answer document on this withdrawal is available in the grid below.

Posted on the EMA website on 28 June 2019