Monthly News Round Up - August 2013
FDA Approves GSK’s Tivicay to Treat HIV Infection
The U.S. Food and Drug Administration has approved GlaxoSmithkline’s Tivicay (dolutegravir), an oral treatment for HIV-1 infection. Tivicay, an integrase inhibitor, interferes with an enzyme necessary for HIV to multiply. Tivicay was evaluated in four trials with over 2,500 participants who received Tivicay or Isentress (raltegravir), each in combination with other antiretroviral drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine and tenofovir. Results showed Tivicay-containing regimens were effective in reducing viral loads and well tolerated. Tivicay is also approved for children ages 12 years and older weighing at least 88 pounds who have not previously taken other integrase inhibitors.
Trokendi XR Approved for Epilepsy
According to the Epilepsy Foundation, epilepsy affects nearly 3 million Americans at an estimated annual cost of $17.6 billion. The U.S. Food and Drug Administration has approved Trokendi XR, an extended-release formulation of topiramate given once daily. Trokendi XR is indicated for initial monotherapy in patients 10 years and older with partial onset or primary generalized tonic-clonic seizures; adjunctive therapy in patients 6 years and older with partial onset or primary generalized tonic-clonic seizures, and as adjunctive therapy in patients 6 years and older with seizures associated with Lennox-Gastaut syndrome. The product will be available in 25, 50, 100 and 200 milligram extended-release capsules.
Epaned: A Liquid Enalapril Approved for Children and Adults
Epaned (enalapril maleate Powder for Oral Solution) has been FDA-approved for hypertension (high blood pressure) in people one month and older who need a liquid formulation. Enalapril is called an ACE Inhibitor, in the same class of medicines as the widely prescribed lisinopril. In children the effects of high blood pressure can begin during childhood. Mild to moderate high blood pressure usually has no symptoms but may be linked with subtle changes in behavior or school performance. Childhood obesity rates in the US have tripled in the last 30 years, which may contribute to high blood pressure. Children should have their blood pressure checked at least once per year.
Valchlor Now Approved for Early Stage Cutaneous T-Cell Lymphoma
Ceptaris Therapeutics has received approval of Valchlor (mechlorethamine) Gel for the topical treatment of stage IA/IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Valchlor is the first FDA-approved topical formulation of mechlorethamine, commonly known as nitrogen mustard. Mechlorethamine is also approved for intravenous treatment of mycosis fungoides, the most common type of CTCL. Valchlor gel is applied topically once a day. In clinical trials, no systemic absorption of mechlorethamine was detected with Valchlor treatment.
Galderma Receives Approval of Mirvaso Gel for Rosacea
The U.S. Food and Drug Administration has approved Mirvaso (brimonidine) topical gel 0.33%, an alpha-2 adrenergic agonist for the treatment of facial redness associated with rosacea. Rosacea is a chronic skin disorder that leads to redness, visible blood vessels, blemishes and inflammatory lesions of the face. It usually starts on the cheeks and nose, but can also affect the forehead and chin. Mirvaso gel is applied once daily and is used in adults. Mirvaso should be used cautiously in patients with depression or certain heart or autoimmune disorders. Oracea (doxycycline) and Metrogel (metronidazole) are treatments approved for the more inflammatory lesions of rosacea.
Posted: August 2013