In particular, the CHMP recommended authorizing the Sanofi vaccine against Covid-19 VidPrevtyn Beta (recombinant, adjuvanted) as a booster in adults previously protected with a Covid-19 mRNA or adenoviral vector vaccine. and the seventh recommended vaccine in the European Union (EU) to protect against this virus and, together with already authorized vaccinations, will support vaccination campaigns in EU member states during the pandemic.
The committee also adopted a positive opinion for a biosimilar drug, Kauliv (teriparatide)for the treatment of osteoporosisa health condition that weakens bones, making them brittle and more likely to break.
On the other hand, Europe has given the green light to the generic drug Pirfenidone Viatris (pirfenidone) for the treatment of idiopathic pulmonary fibrosis, a chronic and progressive condition in which the lungs become scarred and breathing becomes increasingly difficult. In this same line, another generic, Sugammadex Amomed (sugammadex)was recommended for reverse neuromuscular block induced by rocuronium in adults and children or by vecuronium in adults, i.e. it is used to accelerate recovery from the muscle relaxant effects caused by drugs used in surgery.
Extensions of the therapeutic indication of 11 drugs
In this meeting, the committee also assessed art indication extensions for 11 medicines already authorized in the EU: Ceprotin, Comirnaty, DuoPlavin, Dupixent, Enhertu, Eylea, Imfinzi, Iscover, Lynparza, Plavix and Xofluza.
Also, they reported it withdrew two requests for authorization marketing. The medicines concerned are Orepaxam for the treatment of pulmonary arterial hypertension and Febseltiq for the treatment of cholangiocarcinoma (cancer of the bile ducts). In this same sense, two requests for extension of therapeutic indications: Gavreto for the treatment of certain types of thyroid cancer and Ilaris for the treatment of Schnitzler’s syndrome, a rare inflammatory disease that causes long-term urticaria, relapsing fever, bone pain and swelling of the joints and lymph nodes.
Extension of the Comirnaty vaccine to children
The committee recommended extending the use of Covid-19 Company vaccine targeting the parent strain and Omicron’s BA.4 and BA.5 subvariants in children from 5 to 11 years old.
The CHMP endorsed the actions recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimize the risk of serious side effects with Janus kinase (JAK) inhibitors. used to treat various chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer, and severe infections.
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