Posted from: Wednesday, July 17, 2019 - 09:17 AM - Present

New Nucala Dosage Forms Approved

June 6, 2019 – The U.S. FDA has approved two new dosage forms for Nucala® (mepolizumab), manufactured by GlaxoSmithKline. The drug, which is indicated to treat severe eosinophilic asthma (SEA) and eosinophilic granulomatosis with polyangiitis (EGPA), will now be available in autoinjector and pre-filled syringe forms for self-administration.

First approved in 2015, Nucala is now the first anti-interleukin-5 (IL5) biologic to receive FDA approval for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector. It was previously available only as a lyophilized powder that required reconstitution and administration by a healthcare professional.

In clinical studies, patients were able to successfully administer Nucala using the autoinjector or prefilled syringe, and the majority preferred at-home administration. Both dosage forms were found to have a pharmacokinetic and pharmacodynamic profile comparable to that of the lyophilized powder form.

Recommended dosing is 100mg administered via subcutaneous (SC) injection once every four weeks for SEA, and 300mg (three separate 100mg injections) via SC injection once every four weeks for EGPA. Nucala should not be used for relief of acute bronchospasm (contraction of the airways) or status asthmaticus (a severe asthma attack that does not respond to rescue medication).

Both new dosage forms have launched at an average wholesale price (AWP) of $3,545.68 per autoinjector or prefilled syringe – the same cost as a vial of the lyophilized powder form.

Last Updated Friday, October 11, 2019 - 08:38 AM.