DPI developer Iconovo said that the FDA “has issued a positive guidance regarding the generic substitutability of the company’s proprietary inhaler ICOpre with the original drug Breo Ellipta with respect to external design and operating principles” and indicated that the device is suitable for an ANDA for a generic of Breo Ellipta fluticasone furoate/vilanterol DPI. In 2019, Iconovo announced that it was developing the ICOpre pre-filled multidose device for use in generics of GSK’s Ellipta products.
According to Iconovo, the company had recently modified the ICOpre inhaler based on results of a human factors study and earlier advice from the agency. The company also says that it is currently still looking for a partner for development of a a generic Breo/Relvar using the device.
Iconovo CEO Johan Wäborg commented, “We are very pleased to have received this important guidance regarding ICOpre from the FDA. The FDA assesses that ICOpre with its current design can be used in an ANDA process in the US. This is another positive message that we will take with us in the negotiations. Advisory feedback from the FDA is an important competitive advantage in this situation.”
Iconovo also announced that it has reclaimed intellectual property related to the ICOone dry powder delivery device, which it had licensed to ISR in 2021 for development of a vaccine against SARS-CoV-2. According to Iconovo, ISR failed to make milestone payments under the deal and has recently filed for bankruptcy. The company notes that it is still working with Monash University on an ICOone-based inhaled oxytocin and that Affilogic, a French biotech, is using the ICOone for development of an antiviral.
Read the Iconovo press release on the ICOpre.
Read the Iconovo press release on the ICOone.
