|Incyte Says FDA Updates Prescribing Info for Jakafi; RBC Says Amgen's AMG-386 Will Need to See Increases in Overall Survival Benefits Before FDA Approval|
|By Staff and Wire Reports|
|Wednesday, 12 June 2013 18:47|
Incyte Corporation (Nasdaq: INCY) announced the U.S. FDA has updated prescribing information for Jakafi® (ruxolitinib) to include new recommended dosing guidance for patients with low platelet counts and additional safety information. Approved in November 2011, Jakafi is the first and only FDA-approved product for the treatment of patients with intermediate or high-risk myelofibrosis.
The prescribing information for Jakafi now includes a new recommended starting dose of 5 mg twice daily of Jakafi for patients with baseline platelet counts between 50–100 x 10^9/L (50,000 to 100,000) and the flexibility for subsequent dose modifications based on safety and efficacy. The FDA decision to expand the dosing information followed a review of the supplemental New Drug Application (sNDA), which included data from an ongoing Phase II trial (Study 258) of patients with baseline platelet counts of 50,000 to 100,000. In this trial, the starting dose of 5 mg twice daily could be adjusted up or down based on protocol defined hematology criteria with a target dose of 10 mg twice daily to achieve clinical response. The safety and efficacy findings from the current interim analysis of Study 258 are generally consistent with the results observed in the pivotal, phase III COMFORT-I and COMFORT-II program.
“The expanded dosing guidance provides physicians with important new information intended to help patients with low platelet counts experience the clinical benefits of Jakafi, including meaningful spleen reduction and symptom improvement,” stated Paul Friedman, M.D., Incyte's President and Chief Executive Officer.
Additionally, new safety information has been added to the Warnings and Precautions section of the prescribing information stating: Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate.
Language has also been added to the Patient Counseling Information section advising healthcare professionals to inform patients regarding the early signs and symptoms of PML.
These changes to the prescribing information are based on one known case of PML with an undetermined relationship to ruxolitinib in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product. There are reports in the medical literature to suggest that patients with myeloproliferative neoplasms, including myelofibrosis, may be at higher risk of developing PML1-4.
Amgen's (NASDAQ: AMGN) ovarian cancer drug AMG-386 will need to show palpable increases in overall survival benefits in order to gain FDA approval, according to RBC analyst Michael Yee in a research note from earlier.
Investors in Amgen are responding negatively to news a study on AMG-386 met its primary endpoint. Shares of the stock down about 1.5 percent to $96.47.
Yee called the data on the survival benefit an “incremental positive” amid expectations which were extremely low. The analyst believes the benefit data supporting the trial may not be out to the FDA until next year. If approved, Yee sees revenue for the drug in the $300-500 million range.
RBC's Yee maintains an Outperform rating and $120 price target on shares of Amgen.
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Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced that the 14th North American Lysosomal Storage Disorder (LSD) Registries Meeting will take place June 13-14 in Chicago, Illinois.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced results from a meta-analysis study of Lymphoseek® (technetium Tc 99m tilmanocept) Injection, a novel, receptor-targeted, small-molecule radiopharmaceutical.
NuVasive, Inc. (NASDAQ: NUVA) a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that it received a ruling from the U.S. District Court in regards to ongoing royalty rates for Phase I of its patent litigation with Medtronic.
Ohr Pharmaceutical, Inc. (OTCQB: OHRPD), a pharmaceutical company focused on the development of novel therapeutics for large unmet medical needs, today announced that it has received confirmation that its application to list the company's common stock on the NASDAQ Capital Market has been approved by The NASDAQ Stock Market, a unit of the NASDAQ OMX Group.
RTI Biologics Inc. (RTI) (Nasdaq: RTIX), a leading provider of orthopedic and other biologic implants, announced today its intent to acquire privately held Pioneer® Surgical Technology (Pioneer), headquartered in Marquette, Mich.
Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today announced that Dr. Tim Bertram, the Company's President of Research and Development and Chief Scientific Officer, will participate in a panel at the International Society for Stem Cell Research (ISSCR) 11th Annual Meeting being held June 12th-15th, 2013 in Boston, Massachusetts.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today the results of a Phase IIa study of oral laquinimod designed to assess safety, tolerability and clinical efficacy in patients with active lupus nephritis, one of the most serious manifestations of systemic lupus erythematosus (SLE or lupus) that can lead to chronic kidney failure.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that it has entered into a settlement agreement with Wyeth/Pfizer and Altana/Nycomed to resolve all claims relating to Teva’s sales, commencing in December 2007, of its 20 mg and 40 mg generic Protonix® (pantoprazole sodium) tablets.