Hodinový prehľad - Zdravotnícke a vedecké zaujímavosti

Súhrn: The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use has recommended granting a marketing authorization for hormone replacement therapy estetrol (Fylrevy, Gedeon Richter) to treat postmenopausal women who have estrogen deficiency symptoms and who have either had a hysterectomy or have not had a period for at least 12 months Estetrol has been shown to lead to a statistically significant reduction in the frequency and severity of moderate-to-severe menopausal vasomotor symptoms, such as hot flashes and night sweats, compared with placebo Estetrol is a sex hormone and modulator of the genital system, which works by substituting for the loss of estrogen production in postmenopausal women.

Súhrn: Conditional marketing authorization is granted when a medicine fulfills an unmet medical need even though additional data is still required and has been agreed to be provided at a later stage MASH, previously known as nonalcoholic fatty liver disease, occurs when excess fat cells cause chronic inflammation in the liver The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization to semaglutide (Kayshild, Novo Nordisk) for adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis.

Súhrn: The review comes after emerging information raised questions about how the manufacturer handled the database for the main study supporting the drug’s approval “Serious questions” have been raised about whether data had been amended and may thus impact the study’s results and reliability, the EMA said The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use has started a review of avacopan (Tavneos, Amgen), a drug authorized in the EU for treating adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Súhrn: ) to include treatments of adults with squamous cell carcinoma of the anal canal (SCAC) that cannot be removed by surgery and is metastatic or locally recurrent It is used in combination with the chemotherapy drugs carboplatin and paclitaxel There are currently no medicines specifically authorized for use in the EU for the treatment of SCAC, highlighting the unmet need for new treatment options for patients with advanced disease.