The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including two orphan medicines, at its October 2018 meeting7.
A) The six medicines recommended for approval are:
1. Takhzyro - for the prevention of recurrent attacks of hereditary angioedema (HAE)
On October 18, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the orphan medicinal product Takhzyro, intended for the prevention of recurrent attacks of hereditary angioedema.
Takhzyro will be available as a 300-mg solution for injection. The active substance of Takhzyro is lanadelumab, a monoclonal antibody that inhibits active plasma kallikrein proteolytic activity. Increased plasma kallikrein activity leads to angioedema attacks in patients with hereditary angioedema through the proteolysis of high-molecular- weight kininogen and bradykinin. Lanadelumab provides sustained control of plasma kallikrein activity and thereby limits bradykinin generation in patients with hereditary angioedema.
The applicant for this medicinal product is Shire Pharmaceuticals Ireland Limited8.
2. Flucelvax Tetra - for prophylaxis against influenza
On October 18, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Flucelvax Tetra, intended for prophylaxis against influenza.
Flucelvax Tetra will be available as a suspension for injection in pre-filled syringes. The active substance of Flucelvax Tetra consists of influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated and prepared in cell cultures, of 4 different influenza virus strains (two A subtypes and two B types). Flucelvax Tetra provides active immunisation against influenza virus by inducing humoral antibodies against the haemagglutinins.
These antibodies neutralise influenza viruses.
Download >> European Medicines Agency Recommends Approval Of Six Medicines In Its October Meeting
Footnotes
8 https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-takhzyro_en.pdf
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