EMA human medicines committee (CHMP) highlights, November 2022

Four medicines recommended for approval in the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP)’s latest meeting included a biosimilar for osteoporosis and a novel COVID-19 vaccine.

VidPrevtyn Beta, recommended as a new recombinant, adjuvanted booster COVID-19 vaccine in adults previously vaccinated with an mRNA or adenoviral vector COVID-19 vaccine, is the seventh COVID-19 vaccine recommended for approval in the European Union (EU).

The committee adopted a positive opinion for Kauliv (teriparatide), a new biosimilar for osteoporosis, which causes bones to become fragile, increasing their risk of breaking.

New generic medicine Pirfenidone Viatris (pirfenidone), received a positive opinion to treat idiopathic pulmonary fibrosis (IPF), a chronic and progressive condition where the lungs become scarred and breathing becomes increasingly difficult.

Sugammadex Amomed (sugammadex) was given a positive opinion by the CHMP for helping to reverse neuromuscular blockade induced by muscle relaxants rocuronium in adults and children or vecuronium in adults. These products are used in some types of surgery to help patients recover quicker from the effects of the muscle relaxant.

Indication extension recommendations for 11 medicines

Indication extensions were recommended for medicines authorised in the EU: Ceprotin, Comirnaty, DuoPlavin, Dupixent, Enhertu, Eylea, Imfinzi, Iscover, Lynparza, Plavix and Xofluza.

The human medicines committee’s application withdrawals 

Marketing authorisation applications were withdrawn for two products designated as an orphan medicines: Orepaxam for pulmonary arterial hypertension and Febseltiq to treat cholangiocarcinoma, a cancer of the bile ducts.

Two extensions applications of therapeutic indications were withdrawn for:

Gavreto for certain types of thyroid cancers.

Ilaris for Schnitzler syndrome, a rare inflammatory disease that causes long-term urticaria, recurrent fever, bone and joint pain and swollen lymph nodes. 

COVID-19 update

The EMA’s committee recommended extended use of Comirnaty, a vaccine for the original strain of COVID-19 and Omicron subvariants BA.4 and BA.5 in children five to 11 years.

CHMP’s safety update

The CHMP endorsed measures recommended by the EMA Pharmacovigilance Risk Assessment Committee (PRAC), to minimise the risk of serious side effects (cardiovascular conditions, blood clots, cancer and serious infections) of janus kinase (JAK) inhibitors for treating several chronic inflammatory disorders. This recommendation is the result of an article 20 referral procedure, which is issued for medicines authorised via the centralised procedure in cases of quality, safety or efficacy issues.

Read highlights from the CHMP’s September 2022 meeting.