Hikma Pharmaceuticals announced that the FDA has approved 100 mcg/50 mcg and 250 mcg/50 mcg doses of the company’s fluticasone propionate / salmeterol DPI (VR315), a generic version of Advair Diskus and that the company has launched the inhaler in the US. The FDA had issued a minor CRL in response to the ANDA in September 2020. A previous CRL had been issued in May 2017, and in March 2018, Hikma said that the FDA had asked for an additional clinical trial. The company’s response to that CRL was submitted in November 2019.
In 2015, Hikma acquired Roxane Laboratories, a subsidiary of Boehringer Ingelheim that had licensed VR315 from Vectura in 2011. The approval of the inhaler by the FDA triggers an $11 million milestone payment to Vectura, which notes that this is the first US approval for one of its DPIs.
Hikma CEO Siggi Olafsson commented, “The approval of our generic version of Advair Diskus marks an important milestone in our strategy to develop more complex respiratory products. Through the unwavering dedication of our employees and close collaboration with the Vectura team, we have developed a high quality and substitutable generic product for Advair Diskus that will improve availability of this critical medicine. We are very pleased to have now launched this product and will leverage the investments we have made and the experience we have gained through this process to develop a range of respiratory and other complex treatment options for patients and healthcare providers, helping us to continue to put better health, within reach, every day.”
Vectura CEO Will Downie said, “This is excellent news for Vectura and for people living with asthma and COPD in the US. Approval of this high quality substitutable generic product for Advair Diskus validates Vectura’s rare, industry-leading development capabilities and the strong partnership we have with Hikma. Approval of this product paves the way for our substitutable drug-device combination program, also partnered with Hikma, for generic versions of the GSK Ellipta portfolio, in the coming years.”
Read the Hikma press release.
Read the Vectura press release.
