FDA Approves VALCHLOR
Ceptaris Therapeutics, Inc., has announced that the FDA has granted marketing approval for the orphan drug VALCHLORTM (mechlorethamine) gel for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. VALCHLOR is the first and only FDA-approved topical formulation of mechlorethamine, commonly known as nitrogen mustard. VALCHLOR is a gel that is applied topically once a day and dries on the skin.
Mechlorethamine is a chemotherapeutic agent previously approved for intravenous treatment of mycosis fungoides, the most common type of CTCL. Topical mechlorethamine preparations are currently recommended for the treatment of early stage CTCL by the National Comprehensive Cancer Network (NCCN).
The approval of VALCHLOR was based on a randomized, observer-blinded, non-inferiority pivotal trial comparing VALCHLOR to a pharmacy-compounded mechlorethamine preparation in patients with stage IA-IIA MF-type CTCL. Patients had received at least one prior skin-directed therapy. Qualifying prior therapies included topical corticosteroids, phototherapy, Targretin® gel, and topical nitrogen mustard (mechlorethamine). Patients were not required to be refractory to or intolerant of prior therapies. In the thirteen center study, 260 patients (the vast majority of whom were IA and IB) were enrolled (1:1 randomization), making it the largest randomized study ever conducted in mycosis fungoides-type CTCL. Results of the study were published earlier this year in JAMA Dermatology.
In the study, 60% of patients treated with VALCHLOR had a confirmed response at 12 months, defined as reduction of at least 50% in the Composite Assessment of Index Lesion Severity (CAILS) score, while 48% of those treated with the compounded control achieved a confirmed response. Complete responses constituted a minority of the CAILS overall response. CAILS responses were seen as early as 1 month, with further responses observed through 11 months of treatment. No systemic absorption of mechlorethamine was detected with VALCHLOR treatment.
VALCHLOR will be distributed by Accredo Specialty Pharmacy with target availability in the 4th quarter of 2013. Physicians will be able to prescribe VALCHLOR by visiting www.valchlor.com. Patient support and assistance programs will be available to patients. The program services offered will include reimbursement and financial support for eligible patients, as well as disease and product information.
FDA Approves Mirvaso
Galderma Laboratories, L.P. has announced that the FDA has approved Mirvaso® (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. Galderma expects Mirvaso to be available in pharmacies September 2013.
The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies of one-month duration. The results from both studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. In addition, a long-term study in 276 subjects who used Mirvaso for up to 12-months was also conducted. Mirvaso is a topical gel that may work by constricting the dilated facial blood vessels to reduce the redness of rosacea. Mirvaso should be applied in a pea-sized amount, once daily to each of the five regions of the face: the forehead, chin, nose and each cheek. Mirvaso is safe and well-tolerated.
In controlled clinical trials the most common adverse reactions (incidence ≥ 1%) included erythema, flushing, skin burning sensation, and contact dermatitis. In the long-term study, the most common adverse events (≥4% of subjects) included flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).
FDA and Fluoroquinolone Antibacterial Drugs
The FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may