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Pirfenidone, the first AB-rated (fully substitutable) equivalent to Genentech’s Esbriet®*, to treat patients with idiopathic pulmonary fibrosis, a progressive disease that causes irreversible lung scarring and makes it difficult to breathe.
New post hoc analysis results from the phase III IRIDIUM study that suggests that using Enerzair Breezhaler as a step-up therapy from medium-dose LABA/ICS provides benefit beyond increasing ICS dose alone.
Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.
Under the Agreement, Valeo will be responsible for medical and commercial activities for Enerzair® Breezhaler® and Atectura® Breezhaler® for an initial 8 year period.
AstraZeneca granted an exclusive right to import and distribute the immunological therapy Broncho-Vaxom® for the prevention and
treatment of respiratory tract infections in China (excluding Hong Kong, Macau, and Taiwan).
High-dose, once-daily Enerzair® Breezhaler® [IND/GLY/MF] reduced asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks.
U.S FDA accepted the Roche's supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved US indications.