According to a LinkedIn post by generic device maker Merxin, the FDA has indicated that Merxin’s MRX004 soft mist inhaler is suitable for an ANDA submission for a generic version of Boehringer Ingelheim’s Spiriva Respimat tiotropium bromide SMI. Merxin recently announced that it would sponsor doctoral research at the University of Hertfordshire to support development of the MRX004 SMI.
The post included excerpts from a June 15, 2021 letter from the FDA’s Office of Generic Drugs to the company, including the following quote: “After assessing the comparative (threshold) analyses and sample devices submitted with your CC on April 20, 2021, our preliminary view is that, with respect to external critical design attributes and external operating principles only, your proposed device constituent may be appropriate for submission as part of an ANDA referencing SPIRIVA RESPIMAT (tiotropium bromide, EQ 0.00125 mg base/inh; EQ 0.0025 mg base/inh) Metered Inhalation Spray, NDA 021936.”
Merxin Chief Business Officer Philippe Rogueda commented, “The recent letter of the FDA about MRX004 is another validation of Merxin’s approach to generic inhaler designs. It is our third device confirmed by the FDA for generic substitutability. It is great news for the inhaled therapies: whoever has a molecule can access easily reliable and well-accepted devices to develop and launch their products. The soft mist inhaler market is a vast opportunity. As a world leading inhaler supplier, we are well ahead in the race to bring a soft mist inhaler to the market. We are lucky to have so much talent at Merxin to make it happens.”
