Six new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended six medicines for approval at its February 2021 meeting.

The Committee recommended granting a marketing authorisation for Evrysdi* (risdiplam), the first treatment that can be given orally to patients with certain types of spinal muscular atrophy, a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. Since Evrysdi addresses an unmet medical need, it benefited from support through the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines. Evrysdi was reviewed under EMA’s accelerated assessment programme. For more information, see the press release in the grid below.

The CHMP recommended granting a conditional marketing authorisation for Jemperli (dostarlimab) for the treatment of certain types of recurrent or advanced endometrial cancer.

Orladeyo* (berotralstat) received a positive opinion for the prevention of recurrent attacks of hereditary angioedema (rapid swelling under the skin).

Two biosimilar medicinesAbevmy (bevacizumab) and Lextemy (bevacizumab), received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

The generic medicine Abiraterone Accord (abiraterone) received a positive opinion for the treatment of metastatic prostate cancer.

Five recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for CabometyxEpidyolexOpdivoQuofenix and Sarclisa.

Negative opinions on extensions of therapeutic indication

The CHMP adopted negative opinions for extensions of indication for Elebrato Ellipta (fluticasone furoate / umeclidinium / vilanterol), Temybric Ellipta (fluticasone furoate / umeclidinium / vilanterol) and Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol) to add treatment of patients with asthma. For more information on these negative opinions, see the question-and-answer documents in the grid below.

Outcome of review on Varilrix

The CHMP completed a review of the vaccine Varilrix (live attenuated varicella virus [OKA strain]), used for protecting individuals against varicella (chickenpox), and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU. For more information, see the question-and-answer document in the grid below.

Outcome of review on the use of REGN-COV2 for COVID-19

The Committee completed its review on the use of the monoclonal antibodies casirivimab and imdevimab to treat patients with COVID-19. This review was undertaken to provide a harmonised scientific opinion at EU level to support national decision making on the possible use of the antibodies prior to marketing authorisation. The Agency concluded that the combination also known as REGN-COV2 can be used for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19. For more information, see the public health communication in the grid below.

Guidance to address coronavirus variants

EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address coronavirus (SARS-CoV-2) variants. The CHMP has adopted a reflection paper which details the laboratory (non-clinical), clinical, quality and manufacturing data needed to support the approval of such ‘variant’ vaccines.

New pilot project for early contact with patients

The CHMP started a new pilot project to enhance engagement with patients at the start of review of all marketing authorisation applications for orphan medicines. This one-year pilot will enable patients to share their views on aspects such as quality of life, treatment options and unmet medical needs with the CHMP so they can be aware of all aspects from the beginning. More details of this project can be found in the project overview document.

Posted on the EMA website on 26 February 2021