{"id":379017,"date":"2023-12-14T07:07:15","date_gmt":"2023-12-14T12:07:15","guid":{"rendered":"https:\/\/platohealth.ai\/astellas-secures-ec-approval-for-vms-treatment-fezolinetant\/"},"modified":"2023-12-14T12:41:59","modified_gmt":"2023-12-14T17:41:59","slug":"astellas-secures-ec-approval-for-vms-treatment-fezolinetant","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/astellas-secures-ec-approval-for-vms-treatment-fezolinetant\/","title":{"rendered":"Astellas secures EC approval for VMS treatment, fezolinetant","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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Approval of fezolinetant gives patients in Europe a new nonhormonal treatment option to control hot flashes or night sweats associated with menopause.<\/p>\n<\/div>\n

\n\"Astellas\"Astellas<\/div>\n

The European Commission has approved Astellas Pharma\u2019s Veozatm (fezolinetant) for treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.<\/p>\n

Fezolinetant is a nonhormonal neurokinin 3 (NK3) receptor antagonist. It works by blocking neurokinin B (NKB) binding on the kisspeptin\/neurokinin\/dynorphin (KNDy) neuron to modulate neuronal activity in the hypothalamus, reducing the number and intensity of hot flashes and night sweats.<\/p>\n

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Rates of VMS in Europe range from 56 percent up to 97 percent\u201d<\/p>\n<\/div>\n

These symptoms, also known as VMS, can have a disruptive impact on women\u2019s daily activities and overall quality of life. Rates of VMS in Europe range from 56 percent up to 97 percent, according to some research<\/a>.<\/p>\n

\u201cI\u2019m happy to see\u2026that my patients will soon have this new nonhormonal treatment option available to better control their moderate to severe VMS,\u201d commented Prof. Rossella Nappi from the University of Pavia.<\/p>\n

EC approved the marketing authorisation for Veozatm (fezolinetant) 45mg once daily, for treatment of moderate to severe vasomotor symptoms associated with menopause. \u00a0\u00a0<\/p>\n

Trials supporting approval of Veozatm for VMS<\/h2>\n

The Commission\u2019s approval of Veozatm follows a positive opinion issued in October by the European Medicines Agency\u2019s Committee for Medicinal Products for Human Use (CHMP).<\/p>\n

This opinion was based on the results from the BRIGHT SKY\u2122 programme, which included three Phase III clinical trials to monitor efficacy and safety in women with moderate to severe VMS. These studies (SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4) enrolled some 3,000 patients across Europe, the United States and Canada. Findings<\/a> from the most recent study, SKYLIGHT 4, were presented at The North American Menopause Society Annual Meeting in October 2022.\u00a0<\/p>\n

The marketing authorisation for Veozatm (fezolinetant) is applicable in EU Member States, as well as Iceland, Norway and Liechtenstein. Separately, fezolinetant has been approved in Switzerland.<\/p>\n

Fezolinetant, marketed as Veozah, received US Food and Drug Administration approval in May 2023.<\/p>\n

\u201cWe are proud to have developed an innovative treatment option for a condition that has lacked scientific advancement for too long and look forward to making fezolinetant available in countries across the European Union,\u201d said Marci English, Vice President, Head of BioPharma Development at Astellas.<\/p>\n