FDA approves Gilead's sofosbuvir
FDA approved Sovaldi sofosbuvir (GS-7977) from Gilead Sciences Inc. (NASDAQ:GILD) in combination with ribavirin to treat HCV genotypes 2 and 3 infection -- making the drug part of the first all-oral, interferon-free regimen to be approved worldwide. Sovaldi is also approved in combination with ribavirin and pegylated interferon to treat HCV genotypes 1 and 4 infection. The nucleotide analog HCV NS5B polymerase inhibitor is the third drug with breakthrough therapy designation to be approved by FDA.
23andMe discontinuing health-related genetic testing
Personal genomics company 23andMe Inc. (Mountain View, Calif.) said it will discontinue consumer access to its health-related genetic testing. Late last month, FDA ordered the company to immediately discontinue marketing its Personal Genome Service (PGS) "for medical device uses" for which the product does not have FDA clearance or approval. 23andMe said it will continue to provide ancestry-related information and raw genetic data without interpretation, but only customers who purchased PGS prior to Nov. 22, the date of the FDA warning letter, will receive or have access to health-related results (see BioCentury Extra, Nov. 25).
FDA approves Auxilium's Xiaflex for Peyronie's
Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) gained $2.31 (12%) to $21.63 on Friday after FDA approved an sBLA for Xiaflex collagenase clostridium to treat Peyronie's disease in adult men who have a plaque that can be felt and a curve in their penis greater than 30 degrees. Xiaflex is the first drug approved by FDA for the indication. The REMS for the injectable form of collagenase was updated to include elements to assure safe use (ETASU) for Peyronie's disease due to the risk of serious adverse events including penile fracture. The label also now includes a boxed warning of the risk. Xiaflex is already approved in the U.S., Canada, Australia and the EU, where it is known as Xiapex, to treat Dupuytren's contracture in adult patients with a palpable cord in the hand.
NICE backs Aubagio
The U.K.'s NICE issued a final appraisal determination (FAD) recommending Aubagio teriflunomide from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) to treat active relapsing-remitting multiple sclerosis (RRMS) in patients who do not have highly active or rapidly evolving severe RRMS. The recommendation is contingent on Genzyme providing Aubagio at an undisclosed discount under a patient access scheme. In September, NICE had requested more information from Genzyme, including revised cost-effectiveness estimates reflecting U.K. clinical practice (see BioCentury Extra, Sept. 17).
Nature Medicine retracts GSK paper on IL-7
Nature Medicine retracted a January 2010 paper authored by GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) scientists in China and a researcher at Baylor Medical College on the role of interleukin-7 (IL-7) in autoimmune disease. Earlier this year, GSK investigated the paper after allegations surfaced that the studies the paper was based on were inaccurate. GSK found that data in the paper were "misrepresented" and requested the retraction. The pharma said five R&D employees who were among the named authors on the paper have left. In June, GSK dismissed Jingwu Zang, SVP and head of R&D China, a co-author on the paper (see BioCentury Extra, June 5).
Novartis' LBH589 meets PFS endpoint in PANORAMA-1 trial
Novartis AG (NYSE:NVS; SIX:NOVN) said panobinostat (LBH589) plus Velcade bortezomib and dexamethasone met the primary endpoint of improving progression-free survival (PFS) vs. placebo plus Velcade and dexamethasone in the 768-patient Phase III PANORAMA-1 trial to treat relapsed or refractory multiple myeloma (MM). Novartis declined to disclose details, but said the data will be presented at a medical meeting next year. The pharma reiterated plans to submit an NDA to FDA and MAA to EMA in 1H14 for the oral pan-deacetylase (DAC) inhibitor to treat relapsed or refractory MM.
GSK, Theravance report asthma data for Breo Ellipta
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Theravance Inc. (NASDAQ:THRX) said once-daily fluticasone furoate/vilanterol administered with the dry powder Ellipta inhaler met the primary endpoint in a 990-patient Phase III trial to treat moderate to severe persistent asthma. In the trial, 100/25 ug fluticasone furoate/vilanterol improved 0-24 hour weighted mean serial forced expiratory volume in 1 second (FEV1), the primary endpoint, by 108 mL at the end of the 12-week treatment period vs. once-daily 100 ug fluticasone furoate (p<0.001). The pharma said the data "will inform" its discussions with FDA on the "regulatory requirements of an asthma indication" in the U.S. The product -- a once-daily, fixed dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol -- is already approved in the U.S. and Canada as Breo Ellipta to treat airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations in patients with a history of exacerbations.
Oncolys jumps in trading debut
Oncolys BioPharma Inc. (Tokyo:4588) gained Y930 (36%) to Y3,530 in its first day of trading on Friday on the Tokyo Stock Exchange's Mothers. Earlier this week, the company raised Y4.7 billion ($47.3 million) in an IPO through the sale of 1.8 million shares at Y2,600 -- the top end of its proposed price range of Y2,420-Y,2600. Oncolys' festinavir (OBP-601) is in Phase II testing to treat HIV infection (see BioCentury Extra, Dec. 3).
POLITICS & POLICY
Cox departing FDA
FDA Commissioner Margaret Hamburg announced in an internal memo that Virginia Cox will depart as associate commissioner for external affairs for the agency in January. Cox joined FDA in September 2011. Steven Immergut, acting assistant commissioner for media affairs, will serve as acting associate commissioner for external affairs. Erica Jefferson, deputy director of strategy in FDA's Office of Media Affairs, will serve as acting assistant commissioner for media affairs.