Four New Drugs Recommended for Approval
The EMA Committee for Human Medicines (CHMP) recommended the approval of four medicines at its meeting in November 2022.
The CHMP recommended authorizing the vaccine against COVID-19 Vine Prevtyn Beta (COVID-19 Vaccine (Recombinant, Adjuvanted)) as a booster in adults previously vaccinated with an adenoviral vector or mRNA COVID-19 vaccine. It is the seventh vaccine recommended in the European Union (EU) to protect against COVID-19 and, together with vaccines already authorized, it will support vaccination campaigns in EU Member States during the pandemic. See more information in the news announcement in the grid below.
The committee adopted a positive opinion for a biosimilar medicine, Kauliv (teriparatide), to treat osteoporosis, a health condition that weakens bones, making them brittle and more likely to break.
a generic drug, Pirfenidone Viatris (pirfenidone), received a positive opinion for the treatment of idiopathic pulmonary fibrosis, a chronic, progressive disease in which the lungs become scarred and breathing becomes increasingly difficult.
The CHMP adopted a positive opinion for a generic medicine, Sugammadex Amomed (sugammadex), intended for 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 surgery. Sugammadex is used to speed recovery from muscle relaxant effects.
Recommendations on extensions of the therapeutic indication of 11 drugs
The committee recommended 11 indication extensions for medicines that are already authorized in the EU: ceprotin, commune, Duo Plavin, Dupixent, Enhertu, Eylea, Imfinzi, discover, lynparza, Plavix Y Xofluza.
Two marketing authorization applications were withdrawn: orepaxam* for the treatment of pulmonary arterial hypertension, and febseltiq* for the treatment of cholangiocarcinoma (cancer of the bile ducts).
Two requests for extension of therapeutic indications were withdrawn: Gavreto for the treatment of certain types of thyroid cancer, and Ilaris for the treatment of Schnitzler syndrome, a rare inflammatory disease that causes long-term hives, recurring fever, bone and joint pain, and swollen lymph nodes.
The question and answer documents on the recalls are available in the grid below.
The committee recommended extending the use of the COVID-19 vaccine commune targeting the parent strain and subvariants BA.4 and BA.5 of Omicron in children 5 to 11 years of age.
Summary of all vaccines against COVID-19 authorized in the EU is available on the EMA website.
The CHMP endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimize the risk of serious side effects with Janus kinase (JAK) inhibitors It is used to treat various chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer, and serious infections. This recommendation is the result of an article 20 referral procedure, which is activated for medicines that have been authorized through the centralized procedure in the event of quality, safety or efficacy problems. A public health communication about this referral is available in the grid below.
Agenda and minutes
The agenda for the November 2022 CHMP meeting is published on the EMA website. The minutes of the October 2022 CHMP meeting will be published in the coming weeks.
The key figures from the November 2022 CHMP meeting are represented in the chart below.
*This product was designated as an orphan drug during its development. Orphan designations are reviewed by the EMA’s Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the drug’s orphan status and granting it ten years of market exclusivity. .