Sunovion's COPD nebuliser approved in US

The US regulator has approved the first nebulised long-acting muscarinic antagonist for COPD from Sunovion, offering a device that allows patients to breathe normally while taking their medicine.

Known as Lonhala Magnair, the handheld device is virtually silent and reduces the amount of time required to deliver a dose of glycopyrrolate to two or three minutes.

The device aims to help patients properly inhale their medicine, as poor medication technique very often means drugs don't reach the lungs and can't help control the disease.

Its approval in COPD includes chronic bronchitis and/or emphysema and Sunovion, a subsidiary of Japan’s Sumitomo Dainippon Pharma, expects to launch the product early next year.

Lonhala Magnair is the first use of the Magnair nebuliser, based on the closed eFlow technology system developed by Germany’s PARI Pharma.

Approval is based on data from the clinical trials in the Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer (GOLDEN) programme, which included GOLDEN-3 and GOLDEN-4, two phase 3, 12-week trials comparing LONHALA MAGNAIR with placebo in adults with moderate-to-very-severe COPD.

At study endpoints, individuals in the treatment group demonstrated statistically significant and clinically important changes from baseline in trough forced expiratory volume in one second (FEV1) at Week 12 versus placebo.

An additional study, GOLDEN-5, was a phase 3, 48-week open-label safety trial designed to evaluate the long-term safety and tolerability of Lonhala Magnair in adults with moderate-to-very-severe COPD and included the active comparator, Boehringer Ingelheim's Spiriva (tiotropium bromide) delivered by the HandiHaler device.

Lonhala Maganair was generally well-tolerated in clinical studies, with the most common side effects being exacerbations and cough. The overall treatment emergent adverse events (TEAE) incidences were similar for glycopyrrolate and tiotropium groups over 48 weeks.