Novartis Primed To Re-Energize Respiratory Business, Rivals Close In
Novartis’s once-daily triple combination inhaler, QVM149, and dual inhaler, QMF149, could be the first to gain approval for the treatment of uncontrolled asthma, as positive top-line Phase III data from the IRIDIUM and PALLADIUM trials are released. Other companies may not be far behind, however.
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Any lingering hopes Novartis had that fevipiprant could become a blockbuster have disappeared and the Swiss major has ended development of the asthma drug after two more trials failed, this time for severe disease.
A handful of new products are under review at the European Medicines Agency. Orchard Therapeutics' gene therapy application will be fast-tracked; Roche's filing for its new flu treatment will not.
Issued with a complete response letter from the FDA, the company says it will now submit newer data showing the combination's effects on exacerbations.