Drug regulators have approved a combination of fluticasone and formoterol in a device that can be used with a spacer for treating asthma in children.
The move brings the paediatric pathway in line with that recommended for treating the respiratory condition in adults, according to primary care clinicians.
“We are proud to provide another treatment option in an area of medicine where there is still significant need”
The European Medicines Agency has approved flutiform (pMDI 50/5µg) for twice-daily use in the treatment of children with asthma aged five years and over.
Flutiform pMDI is a combination of fluticasone propionate and formoterol in a single pMDI, otherwise known as a press-and-breathe aerosol inhaler.
It has been available in the UK for the treatment of asthma in adults and adolescents since 2012, noted its manufacturer Napp Pharmaceuticals.
The new paediatric licence provides for a regular maintenance option, with a dose of two puffs 50/5µg twice-daily, when a combination of an inhaled corticosteroid and a long-acting β2-agonist is appropriate.
The updated licence meant children had a new treatment alternative to regulate their asthma, while providing healthcare professionals with an additional option to recommend to patients, said Napp.
The Cambridge-based firm said that the new license was based on six years of clinical and real world evidence.
Paul Schofield, medical director at Napp Pharmaceuticals, said: “Despite the number of combination inhalers available, the majority are not available to treat the youngest patients.
“We are proud to provide another treatment option in an area of medicine where there is still significant need,” he said.
Commenting, Dr Iain Small, a GP from the Peterhead Medical Practice in Aberdeenshire, added: “The combination of fluticasone and formoterol in a device that can be used with a spacer will be a valuable addition to our options for treating asthma in children and will bring our paediatric pathway in line with what we recommend for adults.”
In the UK, flutiform pMDI is licenced for regular twice-daily maintenance treatment of asthma when use of a combination product is appropriate.
It is now licenced in 50/5μg strength for patients aged five years and above, 125/5μg strength for patients over 12 years, and in 250/10μg strength for patients over 18 years.