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Assim como ontem, mais um meddicamento biossimilar aprovado, desta vez na Europa .

 

Resumo na língua original:

The European Commission has approved Imraldi, an adalimumab biosimilar referencing AbbVie’s Humira — making the medication available to treat the same therapeutic indications as Humira, including Crohn’s disease, pediatric Crohn’s disease and ulcerative colitis.

The Aug. 24 decision followed a positive recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use, released in June.

 

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Imraldi will be available for any patient older than 6 years of age with moderate-to-severe active Crohn’s disease who have not responded to corticosteroid or immunosuppressant treatment regimens, or who cannot tolerate standard-of-care therapies. Imraldi will also be approved to treat adult patients moderate-to-severe ulcerative colitis who do not respond to first-line of therapy with corticosteroids and Purinethol (6-mercaptopurine) or Azasan (azathioprine), who are intolerant, or who have medical contraindications for such treatments.

 

 

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publicado às 17:43

Noticias de Crohn - Copy.png

Esta notícia vem ao encontro de outra que publiquei aqui recentemente. O principal beneficio da aprovação destes medicamentos é o seu custo, com o aumento da concorrência neste mercado veremos os preços a ficar mais competitivos e isso é benéfico para o sistema nacional de saúde e possivelmente para os doentes, se eventualmente estes medicamentos deixarem de ser comparticipados a 100% como acontece atualmente.

 

Resumo na língua original:

The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim‘s Cyltezo— a biosimilar of Abbvie’s Humira (adalimumab) — to treat Crohn’s disease, ulcerative colitis and a host of other diseases ranging from rheumatoid arthritis to ankylosing spondylitis.

 

Cyltezo is the German company’s first FDA-approved biosimilar and “marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” Ivan Blanarik, senior vice-president and head of Boehringer Ingelheim’s therapeutic area biosimilars, said in a press release.

 

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publicado às 17:32


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