Gilead Closer to FDA Approval - Analyst Blog

Gilead Sciences, Inc (GILD) received a positive opinion from the Anti-Infective Drugs Advisory Committee of the US Food and Drug Administration (FDA). Gilead is seeking FDA approval for inhalable aztreonam for the treatment of lung infection caused by Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF). 

While the committee voted 15-2 with respect to the drug’s safety and efficacy, there was a unanimous opinion regarding the dosage (75 mg three times daily). Although the FDA is not bound to follow the committee’s decision, it generally does so. Gilead has been assigned a Prescription Drug User Fee Act (PDUFA) date of Feb 13, 2010. 

Currently, the drug is being made available to the patients in the US under the FDA’s Expanded Access Program. The New Drug Application (NDA) for the candidate had been submitted in Nov 2007. Since then, there have been several hiccups in the approval process. In Sep 2008, the drug was denied approval by the FDA, which then asked Gilead to resubmit the application with more data. 

We believe a positive recommendation from the advisory committee might lead to the drug’s approval. In Sep 2009, the drug received conditional marketing approval in Canada and Europe under the trade name Cayston (aztreonam lysine 75 mg powder and solvent for nebuliser solution). Gilead plans to make the product available in Germany and the UK in early 2010. 

Aztreonam formulated with lysine is a proprietary formulation of aztreonam developed specifically for inhalation, which has orphan drug status in the US and Europe. Applications for marketing approval of Cayston are pending in Australia, Switzerland and Turkey. CF is a chronic, debilitating genetic disease that affects the respiratory and digestive systems of approximately 70,000 people worldwide, including 35,000 people in the European Union. 

Cayston was granted conditional marketing authorization to address the unmet medical need of CF patients. A decision regarding full marketing authorization will be based on the completion of the ongoing phase III study examining the efficacy and safety of Cayston compared to Novartis’ (NVS) tobramycin inhalation solution (TOBI) in CF patients with pulmonary P. aeruginosa. We have a Neutral recommendation on Gilead.
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