Monthly News Roundup - January 2014

FDA Approves Farxiga for Treatment of Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) tablets to improve glycemic (sugar) control, along with diet and exercise, in adults with type 2 diabetes. Farxiga is in a newer class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors that lowers blood sugar levels by blocking glucose kidney reabsorption and increasing its excretion. Farxiga’s effectiveness was shown in 16 clinical trials involving more than 9,400 patients. Treatment with Farxiga has been studied alone or in combination with other type 2 diabetes medications, including metformin. Another SGLT2 drug, Invokana (canagliflozin) was also okayed by the FDA in March 2013.

GSK’s Mekinist Plus Tafinlar FDA-Approved for Advanced Melanoma

The U.S. Food and Drug Administration (FDA) has approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for the treatment of patients with aggressive melanoma that cannot be removed by surgery or that has spread to other parts of the body. This kinase inhibitor combination treats melanoma that contains BRAF V600E or V600K mutations that are detected by an FDA-approved test. The combination received Priority Review and was approved through the FDA’s Accelerated Approval program. In the Phase II trial, the median duration of response was 10.5 months for patients treated with the combination of drugs and 5.6 months for patients treated with single-agent dabrafenib.

FDA Approves New Dosing and Formulation for Teva’s Copaxone

The U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceutical’s Copaxone (glatiramer) for three-times-a-week dosing using Copaxone 40mg/mL, a new dose strength. This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis (MS). In addition to the newly approved dose, daily Copaxone 20 mg/mL will continue to be available. Generic versions of the 20 mg/mL dose form are expected to be available in May 2014 as patent protection for the blockbuster is set to expire that month. Copaxone ranked as the top selling MS drug of 2012 with over $3.3 billion in sales.

FDA Advisory Panel Backs Merck’s Ragwitek for Ragweed Allergies

Current treatment for ragweed allergy includes a variety of nasal sprays, as well as shots specifically tailored to target hay fever. On Tuesday, an FDA advisory committee recommended approval of an investigational immunotherapy drug named Ragwitek (Short Ragweed Pollen Allergen Extract) for ragweed allergy. The sublingual (under the tongue) tablet is taken daily beginning 12 weeks prior to ragweed pollen season, and continued throughout. The advisory committee voted positively that Ragwitek meets efficacy and safety endpoints; however, some experts are concerned the agent may not target other types of grass and pollen allergies these patients often face.

Telmisartan: Generic for Micardis Brand Now Available

The U.S. Food and Drug Administration (FDA) has approved Actavis’ telmisartan immediate-release tablets, 20 mg, 40 mg and 80 mg, a generic equivalent to Boehringer Ingelheim's Micardis. Actavis is eligible for 180 days of generic market exclusivity, which means prices may stay elevated during this period. Micardis is an angiotensin II receptor blocker indicated for the treatment of hypertension, to lower blood pressure and cardiovascular risk reduction in patients unable to take ACE inhibitors. For the 12 months ending September 30, 2013, Micardis had total U.S. sales of approximately $274 million, according to IMS Health data.

Posted: January 2014


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