New branded drugs, new generics.
RX CARE: New drugs
FDA approved dronabinol oral solution (Syndros, INSYS Therapeutics), an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol. Dronabinol is indicated for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
“Syndros is the first and only FDA approved dronabinol solution for oral use. It is a liquid that is easy-to-swallow and allows for the dosage to be titrated to clinical effect. Once Syndros has been opened, it does not need to be refrigerated for 28 days,” John N. Kapoor, the company’s chairman, CEO, and president. “We believe that these product features coupled with patient support services will prove to be important differentiators for patients and prescribers and will be key drivers of a successful market launch and sustained growth,” Kapoor said. (www.insysrx.com)
FDA has approved Xiidra (lifitegrast ophthalmic solution) for the treatment of dry eye disease. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist, approved for dry eye disease. “Normal tear production is needed for clear vision and eye health,” said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide a new treatment option for patients with dry eye disease.” (www.shire.com)
Amgen has announced that FDA has approved its Repatha (evolocumab) Pushtronex system, a new, monthly single-dose administration option. Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose. “The Pushtronex system exemplifies Amgen’s continued innovation and commitment to patients,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration. The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide.” (www.amgen.com)
Protein Sciences has announced that FDA has extended the shelf life for Flublok, its seasonal influenza vaccine, to nine months from the date of manufacture. “We are pleased to add an extended shelf life to the list of product improvements we have been able to achieve for Flublok,” said Penny Post, Protein Sciences’ VP regulatory affairs. “We were first able to expand the approved age range for Flublok to everyone 18 years and older in October 2014. In addition to the nine-month shelf life we just achieved, Flublok Quadrivalent is under review and FDA approval is anticipated this fall. We are working towards securing a one-year shelf life as well.” (www.flublok.com)
FDA has approved Allergan’s Byvalson (nebivolol 5 mg and valsartan 80 mg) tablets. The drug is indicated to treat hypertension, and according to the product maker it is the first fixed-dose combination of a beta-blocker and an angiotensin II receptor blocker in the United States.
“Achieving blood pressure control is critical to reducing the risk of serious and life-threatening cardiovascular events,” said David Nicholson, Allergan’s chief R&D officer. “There remains a need for new therapies, as observed by the nearly half of patients in the United States who remain uncontrolled. We are pleased with the FDA approval of Byvalson, which will provide physicians a new fixed-dose combination therapy treatment option for patients affected by hypertension.” (www.cia1.allergan.com)
Takeda Pharmaceuticals and Lundbeck have announced the availability of its Trintellix (vortioxetine), a once-daily oral medication to treat adults with major depressive disorder. Trintellix is available in 5-, 10- and 20-mg tablets. (www.lundbeck.com)
Comfort Vision has announced the addition of a 90-pack configuration for ProOcular daily disposable contact lenses. Previously, ProOcular daily disposable lenses were available only in 30-pack cartons. “Our close partnerships with eye care practitioners helped identify the opportunities available with a 90-pack option. Now, 90-pack and 30-pack configurations will enable practitioners to more easily dispense affordable ProOcular daily disposable lenses.” said Wei-Yung Lee, CEO of Comfort Vision. (www.comfort-vision.com)
FDA has approved an expansion to the prescribing information for darunavir (Prezista, Janssen Therapeutics), to treat pregnant women with HIV.
“The recent label update includes dosing recommendations for pregnant women with HIV, and data demonstrates that Prezista taken with ritonavir was found to be well-tolerated during pregnancy and the postpartum period,” said Janssen Therapeutics, a division of Janssen, in a statement.
An (HIV-1) protease inhibitor, Prezista is for the treatment of HIV-1 infection in adult and pediatric patients three years of age and older in combination with ritonavir with other antiretroviral agents. (www.janssentherapeutics.com)
FDA has approved CIV extended-release 20 mg tablets (Belviq XR, Eisai Inc. and Arena Pharmaceuticals), a once-a-day dosing option for chronic weight management. Belviq XR is expected to be available in fall, 2016. “With approximately two-thirds of the U.S. population living with extra weight or obesity, there is a significant and growing need to address chronic weight management,” said Louis J. Aronne, MD, director of the Comprehensive Weight Control Center at Weill Cornell Medicine, physician at New York-Presbyterian/Weill Cornell Medical Center, and principal investigator of the Belviq clinical trials.
Belviq is slowly absorbed and lasts throughout the day, according to Eisai. Both the original 10 mg twice-daily formulation of and newly-approved 20 mg once-daily extended release formulation are approved for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a BMI of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition. (www.arenapharm.com)
FDA has granted Aurobindo Pharma Limited final approval for Hydrocodone Bitartrate and Ibuprofen Tablets,7.5 mg/200 mg. FDA determined Aurobindo’s Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg bioequivalent and therapeutically equivalent to Vicoprofen Tablets of (AbbVie Inc.) The product is approved for short-term management of acute pain. (www.aurobindo.com)