Four new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended four medicines for approval at its November 2022 meeting.
The CHMP recommended authorising the COVID-19 vaccine VidPrevtyn Beta (COVID-19 vaccine (recombinant, adjuvanted)) as a booster in adults previously vaccinated with an mRNA or adenoviral vector COVID-19 vaccine. It is the seventh vaccine recommended in the European Union (EU) for protecting against COVID-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic. See more information in a news announcement.
The committee adopted a positive opinion for a biosimilar medicine, Kauliv (teriparatide), for the treatment of osteoporosis, a health condition that weakens bones, making them fragile and more likely to break.
A generic medicine, Pirfenidone Viatris (pirfenidone), received a positive opinion for the treatment of idiopathic pulmonary fibrosis, a chronic and progressive condition in which the lungs become scarred and breathing becomes increasingly difficult.
The CHMP adopted a positive opinion for generic medicine, Sugammadex Amomed (sugammadex), intended for the reversal of neuromuscular blockade induced by rocuronium in adults and children or vecuronium in adults. Rocuronium and vecuronium are muscle relaxants used during some types of surgeries. Sugammadex is used to speed up the recovery from the effects of the muscle relaxant.
Recommendations on extensions of therapeutic indication for 11 medicines
The committee recommended 11 extensions of indication for medicines that are already authorised in the EU: Ceprotin, Comirnaty, DuoPlavin, Dupixent, Enhertu, Eylea, Imfinzi, Iscover, Lynparza, Plavix, and Xofluza.
Withdrawals of applications
Two applications for marketing authorisation were withdrawn: Orepaxam* for the treatment of pulmonary arterial hypertension, and Febseltiq* for the treatment of cholangiocarcinoma (cancer of the bile ducts).
Two applications for extensions of therapeutic indications were withdrawn: Gavreto for the treatment of certain types of thyroid cancer, and Ilaris for the treatment of Schnitzler syndrome, a rare inflammatory disease causing long-term urticaria, recurrent fever, bone and joint pain, and swollen lymph nodes.
The committee recommended extending the use of COVID-19 vaccine Comirnaty targeting the original strain and Omicron subvariants BA.4 and BA.5 in children between 5 to 11 years of age.
An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website.
The CHMP endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of serious side effects with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections. This recommendation is the outcome of an article 20 referral procedure, which is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.
*This product was designated as an orphan medicine during its development. Orphan 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.