logo
Plus   Neg
Share
Email

Vertex: European Commission Approves KALYDECO To Treat Infants With Cystic Fibrosis

Vertex Pharmaceuticals Incorporated (VRTX) announced the European Commission has granted approval of the label extension for KALYDECO (ivacaftor) granules to include
the treatment of infants with cystic fibrosis ages 4 months and older. The company said the label update is based on data from a cohort in the 24-week phase 3 open-label safety study (ARRIVAL) consisting of six children with cystic fibrosis ages four months to less than six months who have eligible gating mutations.

KALYDECO will be now available to additional eligible patients in Germany and will be available shortly in countries that have entered into long-term reimbursement agreements with Vertex, including the UK, Denmark and the Republic of Ireland.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The restaurant industry continues to struggle in pandemic conditions with January consumer spending in restaurants well below pre-pandemic levels, according to new data released by the National Restaurant Association or NRA. Despite the slowdown in COVID-19 outbreaks and the increased distribution of vaccines, most restaurant operators do not expect a return-to-normal business conditions any time. Chico's FAS Inc. (CHS) Tuesday reported a wider year-over-year net loss for the fourth quarter. Meanwhile, Kohl's Corp.'s (KSS) fourth-quarter net income grew 29 percent from the previous year. But Abercrombie & Fitch Co.'s (ANF) fourth-quarter net income decreased 1 percent from the prior year. The U.S. Food and Drug Administration has approved the marketing of a new robotically-assisted surgical device (RASD) that can facilitate transvaginal hysterectomy in certain patients using minimally-invasive surgical instruments. The Hominis Surgical System of Memic Innovative Surgery Ltd., the U.S. subsidiary of Israeli biotechnology company memic Ltd., has been granted marketing authorization.
Follow RTT