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February FDA drug approvals


FDA actions in brief, complete response, breakthrough therapy designation, fast-track designation

Actions in brief

Glatiramer acetate injection (Copaxone, Teva Pharmaceutical Industries Ltd.) 3-times-a-week 40 mg/mL dose was approved for patients with relapsing forms of multiple sclerosis (MS). This new formulation will allow for a less-frequent dosing regimen.

Diclofenac sodium topical solution (Pennsaid 2%, Nuvo Research and Mallinckrodt) was approved for the pain of osteoarthritis of the knee.

Tasimelteon (Hetlioz, Vanda Pharmaceuticals), a melatonin receptor agonist was approved to treat non-24-hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.

PillCam COLON (Given Imaging) has been given clearance for detection of colon polyps in patients after an incomplete optical colonscopy with adequate preparation and a complete evaluation of the colon was not technically possible. PillCam COLON received clearance under the direct de novo classification for devices with low to moderate risk that have no predicate on the market.

Complete response

RHB-103 (RedHill Biopharma and IntelGenx), an oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist, for the treatment of acute migraines. The questions raised by FDA in the complete response letter (CRL) regarding the NDA for RHB-103 primarily relate to third-party Chemistry, Manufacturing and Controls and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and FDA’s CRL does not require additional clinical studies. While continuing to review FDA’s CRL, RedHill and IntelGenx believe that they can supply the requested information based on available data. IntelGenx and RedHill further believe that the majority of issues raised by FDA were recently addressed in an amendment submitted by the companies to FDA that has yet to be reviewed. The companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information.

Ferumoxytol (Feraheme, AMAG Pharmaceuticals) injection supplemental New Drug Application (sNDA) for intravenous (IV) use. The sNDA sought to expand the indication for Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment. In the complete response letter, FDA stated that AMAG has not provided sufficient information to permit labeling of Feraheme for safe and effective use for the proposed indication. FDA indicated that its decision was based on the cumulative ferumoxytol data, including the global phase 3 IDA program and global post-marketing safety reports. FDA suggested that AMAG generate additional clinical trial data in the proposed broad IDA patient population with a primary composite safety end point of serious hypersensitivity/anaphylaxis, cardiovascular events, and death. Additionally, FDA proposed potentially evaluating alternative dosing and/or administration of Feraheme. AMAG is assessing the content and recommendations of the letter and plans further discussions with FDA.

Breakthrough therapy designation

Eltrombopag (Promacta/Revolade, GlaxoSmithKline) for the treatment of patients with severe aplastic anemia who have had insufficient response to immunosuppressive therapy.

Fast-track designations

Clonidine lauriad (Validive, BioAlliance Pharma) for the prevention and treatment of oral mucositis induced by radiotherapy and/or chemotherapy in cancer patients.

OMS824 (Omeros) phosphodiesterase 10 inhibitor for the treatment of cognitive impairment in patients with Huntington's disease.

Orphan drug designations

Eculizumab (Solaris, Alexion) for preventing delayed graft function in renal transplant patients.

Vatiquinone, EPI-743 (Edison Pharmaceuticals) for the treatment of Friedreich’s ataxia.

BL-8040 (BioLineRx) for treatment for stem cell mobilization, in addition to the orphan drug designation previously granted as a treatment for acute myeloid leukemia.


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