New Products

NEW DRUGS

FDA has approved two new cancer drugs, both from GlaxoSmithKline. Tafinlar (dabrafenib) and Mekinist (trametinib) are approved for use as single agents - not in combination - against melanoma, the deadliest form of skin cancer. Tafinlar was approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation, while Mekinist is for patients with either the BRAF V600E or V600K gene mutations. About half of skin melanomas have a BRAF mutation. FDA also approved the THxID BRAF test, made by France's Biomerieux, which will be used to determine whether a patient's melanoma cells have the V600E or V600K mutation in the BRAF gene. Advanced melanoma patients who received Tafinlar had a delay in cancer growth that was 2.4 months longer than patients treated with a standard chemotherapy drug, dacarbazine. Subjects with the BRAF V600E or V600K gene mutation who received Mekinist had a delay in cancer growth that was 3.3 months longer than that seen in subjects given standard chemotherapy. (www.tafinlar.com / www.us.gsk.com)

In May, Janssen Biotech’s Simponi (golimumab), was approved as a new therapeutic option for patients living with moderately to severely active ulcerative colitis (UC), who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. The product is the first and only subcutaneous biologic treatment approved to induce and maintain clinical response and improve endoscopic appearance of the intestinal lining. Simponi is indicated to induce clinical remission and achieve and sustain clinical remission in induction responders. As many as 700,000 people in the United States are affected by UC, a chronic inflammatory bowel disease marked by inflammation and ulceration of the innermost lining of the colon.To treat UC, the SIMPONI dose regimen consists of 200 mg subcutaneously injected at week 0, followed by 100 mg at week 2 and then 100 mg every 4 weeks, thereafter. (www.simponi.com)

Eisai has announced that Belviq (lorcaserin HCl) CIV tablets, the first prescription treatment option for chronic weight management approved by the FDA in over a decade, is now available in most U.S. pharmacies. Approved by FDA in June 2012, the product may help some obese adults or overweight adults who also have weight-related medical problems lose weight and keep the weight off. It should be used with a reduced-calorie diet and increased physical activity. It is not known whether Belviq is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products, nor is it known whether it changes individual risk of heart problems or stroke, or of death due to heart problems or stroke. (www.belviq.com)

FDA has approved and granted orphan product designation to Raptor Pharmaceuticals’ Procysbi (cysteamine bitartrate) for the management in children and adults of nephropathic cystinosis, the most severe of three types of cystinosis, a rare genetic condition that affects an estimated 500 patients in the United States and about 3,000 patients worldwide. Cystinosis causes cysteine, a protein building block, to build up in every cell of the body. The cysteine buildup causes kidney problems and may lead to slow body growth and small stature, weak bones, and developing and worsening kidney failure. If not treated in early childhood, cystinosis can be fatal. FDA-approved drugs used to treat cystinosis include Cystagon (cysteamine bitartrate), an immediate-release tablet that was approved in 1994, and Cystaran (cysteamine ophthalmic solution) eye drops, from Sigma Tau Pharmaceuticals, approved to treat corneal cystine crystal accumulation and launched in May. Procysbi is a delayed-release capsule intended for patients ages 6 years and older. While Cystagon is taken every six hours around the clock to control cystine levels, Procysbi is a long-acting formulation that is taken every 12 hours. (www.procysbi.com/‎)

FDA recently approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin. This heptavalent antitoxin is the only product available for the treatment of botulism in adults, and for cases of infant botulism caused by nerve toxins other than types A and B. The product, which will be stored in the Strategic National Stockpile for emergency preparedness and responses and distributed through the CDC’s Drug Service, is derived from horse plasma and contains a mixture of antibody fragments that neutralize all of the seven botulinum nerve toxin serotypes known to cause botulism. Botulism is a rare but serious paralytic illness caused by a nerve toxin produced by the bacterium Clostridium botulinum and sometimes by strains of Clostridium butyricum and Clostridium baratii. In the United States, an average of 145 cases are reported each year, and of these, approximately 15% are foodborne, 65% are infant botulism, and 20% are wound-related. In foodborne botulism, symptoms generally begin 18 to 36 hours after eating a contaminated food, but they can occur as early as 6 hours or as late as 10 days. (www.cangene.com)

NEW INDICATION

FDA has approved Genentech’s Tarceva (erlotinib) tablets, used in initial treatment of people with metastatic non-small-cell lung cancer (NSCLC). The approval was based on the results of the Phase III study, named EURTAC, which evaluated the first-line use of Tarceva versus platinum-based chemotherapy in people with EGFR-activating mutation-positive advanced NSCLC. According to Genentech, 10% to 30% of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations. FDA has also approved the cobas EGFR Mutation Test, which was developed by Roche and validated in the EURTAC study. Tarceva is already approved in the U.S, irrespective of histology or biomarker status, for people with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy. (www.tarceva.com/)

NEW GENERICS

Liptruzet, a cholesterol-lowering drug that combines Merck's Zetia (ezetimibe) with atorvastatin (generic version of Pfizer's Lipitor) has been approved by FDA. According to Merck, Liptruzet tablets are for the treatment of high LDL (low-density lipoprotein) cholesterol in patients with primary or mixed hyperlipidemia alongside a special diet when diet alone is not enough. Hyperlipidemia is an excessively high concentration of fats (lipids) in the blood. Merck says this product treats two sources of cholesterolz; with atorvastatin, it reduces the production of cholesterol in the liver; with ezetimibe, it inhibits the absorption of cholesterol in the digestive tract. The dosage range of Liptruzet is 10/10 mg/day to 10/80 mg/day. The product has not been shown to lower the risk of cardiovascular disease, including stroke and heart attack. (www.liptruzet.com)

Late in May, FDA approved trospium chloride ER, a generic drug for incontinence made by Perrigo Co. The 60-mg capsules extended-release capsules are a once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug is a generic version of Allergan's Sanctura XR. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder. The product is now shipping. (www.perrigo.com)

NEW OTC

Nordic Naturals has launched ProEPA Elite, featuring a high dose (1,600 mg per serving) of Omega-3 eicosapentaenoic acid (EPA), an essential fatty acid that has anti-inflammatory properties and supports heart health. Pro EPA Elite is an EPA-only formula that contains a dose of fish oil similar to a much-studied ethyl-ester EPA formulation. This dose of EPA has been demonstrated in clinical studies to be beneficial in reducing triglycerides and other cardiovascular risk factors. Pro EPA Elite differs from the study product in that it is formulated in the more bioavailable triglyceride form that is available over the counter. Nordic Naturals offers four products in varying amounts of omega-3 EPA: ProEPA, ProEPA Xtra, ProEPA Elite, and ProEPA with Concentrated GLA. (www.nordicnaturals.com)