Novartis AG said the European Commission approved Xolair as a self-administered treatment for asthma and hives.
The Swiss pharmaceutical company said Xolair, in prefilled syringes, is the first and only biologic to offer the option to self-inject to patients with severe allergic asthma, or SAA, and chronic spontaneous urticaria, or CSU.
SAA and CSU patients must be at least 6 and 12 years of age, respectively, and with no known history of anaphylaxis, a life-threatening allergic reaction, to use Xolair on themselves. They must also be trained on how to self-administer Xolair.
The approval covers countries in the EU, as well as Iceland, Norway and Liechtenstein.
Novartis said Xolair's effectiveness has been demonstrated in large-scale clinical trials and real-world studies. The drug is typically injected by physicians every two or four weeks at a clinic.
"Decreasing the number of regular clinic visits allows patients the flexibility to fit their treatment around their lives and helps to reduce the burden of these diseases," Karl-Christian Bergmann of Berlin's Allergy Center Charité said. "It also allows physicians a greater capacity for patients who need extra care."
SAA, characterized by the swelling and narrowing of the airways, affects an estimated 235 million people worldwide. CSU is characterized by persistent hives and/or angioedema, which is the painful deeper swelling of the skin tissue. Both diseases due to the body's overproduction of the antibody immunoglobulin E, which Xolair targets.