This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2021
  • /
  • 7
  • /
  • CHMP recommends Nexviadyme, a treatment for for gl...

CHMP recommends Nexviadyme, a treatment for for glycogen storage disease type II

Read time: 1 mins
Published:28th Jul 2021
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nexviadyme,(Lumizyme in the US) intended for the treatment of glycogen storage disease type II (Pompe disease). The applicant for this medicinal product is Genzyme Europe BV.

Nexviadyme will be available as a 100 mg powder for concentrate for solution for infusion. The active substance of Nexviadyme is avalglucosidase alfa, a recombinant human acid alfa-glucosidase (ATC code: not yet assigned), which is an enzyme replacement therapy that provides an exogenous source of acid alfa-glucosidase. The benefit of Nexviadyme is its ability to improve the respiratory function (also called force vital capacity) of Pompe disease patients. The most common side effects are hypersensitivity (including anaphylaxis), infusion associated reactions (pruritus, rash, headache, urticaria, fatigue, nausea and chills).The full indication is: Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid alfa-glucosidase deficiency).

Condition: Pompe Disease
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.