close

Products

Date: 2018-08-13

Type of information: Granting of the Breakthrough Therapy status

Product name: Xolair®

Compound: omalizumab

Therapeutic area: Allergic diseases - Immunological diseases

Action mechanism:

  • monoclonal antibody. Omalizumab is a monoclonal antibody binding to immunoglobulin E (IgE). It suppresses histamine-induced skin reactions, probably through its reduction of IgE and downstream effects on cellular activation mechanisms.
  • In the U.S., Genentech. and Novartis work together to develop and co-promote Xolair®.

Company: Roche (Switzerland)

Disease: food allergies

Latest news:

  • • On August 13,2018, Roche announced that the FDA has granted Breakthrough Therapy Designation for Xolair® (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. This is the 23rd Breakthrough Therapy Designation for Roche's portfolio of medicines.
  • Breakthrough Therapy Designation was granted on the basis of data from seven clinical studies over the last decade assessing the efficacy and safety of Xolair® against a range of food allergens including peanut, milk, egg and others. These studies of Xolair, as monotherapy or in combination with oral immunotherapy, were supported by Genentech and independent sponsors including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
  • Genentech, a member of the Roche Group, and Novartis Pharmaceuticals Corporation are working closely with NIAID and the Consortium of Food Allergy Research (CoFAR) to initiate a potentially pivotal study evaluating the efficacy and safety of Xolair® in multiple food allergies and will disclose details at a later date.
   

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes