CHMP meeting highlights – February 2023

The Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval, gave one negative opinion, plus four positive opinions on therapeutic indications extensions in its February 2023 meeting.

Eight new medicines recommended for approval

The CHMP recommended granting a marketing authorisation for Akeega (niraparib/abiraterone acetate) for metastatic castration-resistant prostate cancer with BRCA 1/BRCA 2 mutations.

The committee adopted a positive opinion for Elfabrio* (pegunigalsidase alfa) for Fabry disease, a rare genetic disorder that results from the build-up of a type of fat in the body cells.

Hyftor* (sirolimus) received a positive opinion from the CHMP for facial angiofibroma. This is a benign vascular skin lesion composed of dermal fibrous tissue and blood vessels. Hyftor is indicated for treating patients over six years old.

The CHMP recommended for Opzelura (ruxolitinib) for non-segmental vitiligo, a skin disorder characterised by depigmented patches of skin. Opzelura is indicated adults and adolescents from 12 years of age.

The committee adopted a positive opinion for Tibsovo* (ivosidenib) for newly diagnosed acute myeloid leukaemia. The treatment was also recommended for locally advanced or metastatic cholangiocarcinoma, a type of cancer that forms in the bile ducts. The committee also adopted a positive opinion for its duplicate Tidhesco* (ivosidenib) for newly diagnosed acute myeloid leukaemia.

The CHMP gave a positive opinion to Vafseo (vadadustat) for symptomatic anaemia in adults with chronic kidney disease (CKD) who are on maintenance dialysis.

Bekemv (eculizumab), the first biosimilar approved for this active substance received a positive opinion for paroxysmal nocturnal haemoglobinuria. This life-threatening genetic disease causes the breakdown of red blood cells resulting in various medical complications. Unlike the reference product, Bekemv is contraindicated in patients with hereditary fructose intolerance and in children below two years old.

Recommendations on extensions of therapeutic indication for four medicines

The committee recommended four extensions of indication for medicines that are already authorised in the European Union (EU): Esbriet, Libtayo, Rinvoq and TachoSil.

Withdrawals of applications by the CHMP

The application to extend the therapeutic indication of Buvidal for chronic pain in people with dependence on opioids was withdrawn.

Re-examination of recommendation

The applicant for Sohonos* has requested a re-examination of EMA’s opinion of January 2023. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.

CHMP COVID-19 updates

The committee recommended authorising the use of COVID-19 Vaccine Valneva (inactivated, adjuvanted) as a booster dose for adults 18 to 50 years of age.

The CHMP recommended the refusal of a marketing authorisation for Lagevrio (molnupiravir) for COVID-19 in adults.

*This product was designated as an orphan medicine during its development. These designations are reviewed by EMA’s Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.