Lupin Healthcare (UK) Ltd has announced that it has received approval from Medicines and Healthcare products Regulatory Agency (MHRA) to market Luforbec (beclometasone/formoterol) 100/6 dose pressurised metered dose inhaler (pMDI).
The product is the first branded generic of Fostair 100/6 µg pMDI, made by privately-held Italian drugmaker Chiesi, and has the potential to offer significant cost savings for the NHS.
Luforbec (beclometasone dipropionate/formoterol fumarate dihydrate) 100/6 µg pMDI is indicated for regular treatment of asthma and for the symptomatic treatment of patients with severe chronic obstructive pulmonary disease, Lupin said.
In the twelve months to February 2021, the NHS spent over GBP 179 million on Fostair 100/6 µg pMDI and the availability of Luforbec 100/6 µg pMDI offers significant savings potential for the NHS, upon launch, it added.
Thierry Volle, president EMEA, Lupin Limited, said: The approval of Luforbec is a pivotal milestone for the UK and a welcome step for Lupin as we draw on our strong expertise in respiratory research and development and expand our respiratory portfolio. We are proud to support healthcare providers and patients by continuing to invest in specialized treatments for chronic diseases.”
Respiratory disease affects one in five people and is the third biggest cause of death in the UK.
"We are truly delighted to receive the first marketing authorization for generic Fostair 100/6 µg pMDI in the UK. This is an important milestone for our respiratory franchise as we expand our product offering across the globe,” Lupin Ltd CEO Vinita Gupta commented.
