BioCentury
ARTICLE | Financial News

Novo receives second CRL for rFXIII, reports 1H13 financials

August 9, 2013 12:53 AM UTC

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) disclosed in its 1H13 earnings on Thursday that it received in June a second complete response letter from FDA for a BLA for recombinant factor XIII ( rFXIII) to treat congenital Factor XIII deficiency, a rare bleeding disorder. According to Novo, FDA said completion of the review of the BLA is "pending the resolution of findings at an inspection of the manufacturing facility." The company said it is working with FDA to address the issues. Novo disclosed that it received the first complete response letter for the product in February 2012 (see BioCentury Extra, May 28, 2012).

Novo also said subcutaneous once-daily 3 mg liraglutide met the primary endpoint of improving mean Apnea-Hypopnea Index (AHI) scores in the Phase IIIa SCALE Sleep Apnea trial to treat obesity in patients with moderate to severe obstructive sleep apnea. The trial is the final of four Phase III trials in the SCALE program evaluating 3 mg liraglutide for weight management in patients who are overweight or obese with or without comorbidities. Novo plans to submit regulatory applications in the U.S. and EU for the 3 mg dose of liraglutide by year end or early 2014. The company markets once-daily 1.2 and 1.8 mg doses of the long-acting analog of glucagon-like peptide-1 (GLP-1) as Victoza in the U.S. and EU to treat Type II diabetes. ...