GMP certification bodes well for Alexza’s lead product
pharmafile | August 28, 2012 | News story | Manufacturing and Production |Â Â Alexza, FDA, GMP, schizophreniaÂ
US drugmaker Alexza Pharmaceuticals’ manufacturing facility for lead product Adasuve has been given a green light from the Spanish medicine regulatory body.
Recognition that Alexza’s facility in Mountain View, California, is complying with Good Manufacturing Practice (GMP) is a boost for the company, whose marketing application for Adasuve (aerosolised loxapine) was turned down by the FDA earlier this year because of manufacturing deficiencies.
The FDA’s Complete Response Letter said that during an inspection “our field investigator conveyed deficiencies to the representatives of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved”.
Now, Spain’s Agencia Espanola de Medicamentos y Productos Sanitarios (AEMPS) awarded Alexza an EU Certificate of GMP Compliance for the facility based on a May inspection of the plant. The initial certificate is valid through May 15, 2015.
Adasuve was submitted for approval in the US as a treatment for agitation associated with schizophrenia or bipolar I disorder in adults, but has had a tough time securing regulatory approval, having been turned down by the FDA for the first time in 2010 because of deficiencies in Alexza’s Risk Evaluation and Mitigation Strategy (REMS) for the product.
After being turned down again in May of this year because of the manufacturing problems, Alexza resubmitted its marketing application in June and is now due to hear the FDA’s verdict by December 21.
The product makes use of Alexza’s proprietary Staccato technology, which vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.
The company says that approach means the active substance is absorbed rapidly into the bloodstream, rivalling the onset of action of injectable drugs but in a more patient-friendly formulation.
Adasuve has also been filed for approval in Europe, where it will be marketed by Grupo Ferrer, and Alexza has been responding to queries about the application from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
A list of outstanding issues drawn up by the CHMP also covered certain manufacturing issues – none of which were ‘critical’ or ‘major’, said Alexza chief executive Thomas King on a recent conference call.
He noted that the EU and US teams took a slightly different approach to their inspections, with the EMA focusing a lot on observing production and analytical processes, while the FDA puts greater emphasis on documentation and record-keeping.
The company has developed an action plan to correct the observations and expects to hear the CHMP’s verdict on its application by the end of the year.
Phil Taylor
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