FDA rejects GSK's Nucala in COPD, asking for more clinical data
The US regulator has rejected GlaxoSmithKline's pulmonary disease drug Nucala in a potential new chronic obstructive pulmonary disease (COPD) use.
In July, Nucala (mepolizumab), which is already approved and established in asthma, was dealt a blow when the FDA’s Pulmonary-Allergy Drugs Advisory Committee said that the drug was not effective for COPD.
Although the FDA committee's votes are non-binding, the regulator usually follows their advice.
The FDA's dreaded complete response letter (CRL) said that more clinical data is needed before approval can be granted, unsurprising news in the wake of the committee’s earlier stance.
In a statement, GSK said: “The CRL states that more clinical data are required to support an approval. GSK will work closely with the FDA to determine the appropriate next steps for the supplementary biologics license application.”
Nucala is already approved to treat severe asthma and GSK hopes to eventually market the medicine as an add-on treatment to inhaled corticosteroid-based maintenance treatment.
It was hoped that the drug would help COPD patients with high eosinophilic counts. Eosinophils are a type of white blood cell, which, when overproduced, can cause inflammation in vital organs and tissues, sometimes permanently damaging them. They are believed to contribute to the development of inflammatory diseases including severe asthma and COPD.
If approved, Nucala would be the first biologic treatment for patients with COPD.
COPD is the umbrella term for a group of lung diseases that make it difficult for a patient to empty their lungs of air, as well as fill their lungs, because their airways have narrowed due to inflammation, tissue damage or problems with the lining of the airways.
The drive to find a drug that meets the needs of patients with COPD is ongoing. In May, AstraZeneca’s severe asthma drug Fasenra (benralizumab) failed a phase 3 trial.
Fasenra missed the primary endpoint of its study – failing to significantly cut down on episodes when symptoms suddenly flared up.