Monthly News Roundup - March 2014
Biogen Idec’s Orphan Drug Alprolix Approved for Hemophilia B
Hemophilia B is an inherited sex-linked, blood-clotting disorder, which primarily affects males, and is caused by defects in the Factor IX gene. The U.S. Food and Drug Administration (FDA) has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require fewer injections. Alprolix consists of the Factor IX molecule, but it’s linked to the protein fragment Fc found in antibodies and this lengthens its time in circulation. Clinical studies in 123 individuals with severe Hemophilia B, ages 12 to 71 demonstrated the effectiveness and safety of Alprolix.
Impavido FDA-Approved for the Tropical Disease Leishmaniasis
The U.S. Food and Drug Administration (FDA) has approved Paladin Therapeutics' Impavido (miltefosine) to treat a parasitic tropical disease called leishmaniasis in patients 12 years of age and older. Leishmaniasis is acquired through the bite of a sandfly. Impavido is an oral medicine for the three main types of leishmaniasis: visceral, cutaneous, and mucosal leishmaniasis. Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis. Impavido is generally is well tolerated, with gastrointestinal (stomach) side effects like nausea, vomiting, and diarrhea most commonly reported. The labeling for Impavido includes a boxed warning about fetal harm and should not be given in pregnancy.
Celgene’s Otezla is FDA-Approved For Psoriatic Arthritis
Psoriatic arthritis (PsA) is a form of arthritis that may affect people with psoriasis. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Many injectable treatments for this condition, such as the tumor necrosis factor (TNF) blockers Humira (adalimumab) or Enbrel (etanercept), are well-known. However, Otezla (apremilast) is an oral phosphodiesterase-4 (PDE-4) and injection-weary patients may prefer this new dosage form. In clinical trials, Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo. Celgene is also seeking approval of Otezla for psoriasis with an FDA decision expected in September.
FDA Approves Mallinckrodt’s Xartemis XR
The U.S. Food and Drug Administration (FDA) has approved Xartemis XR (oxycodone hydrochloride and acetaminophen) 7.5 mg/325 mg Extended-Release Tablets for the management of acute, severe pain. The approval is based, in part, on the Phase 3 efficacy study conducted in patients with acute post-surgical pain. Xartemis XR has both immediate- and extended-release components, is given twice a day, and is formulated to provide onset of pain relief in less than one hour. Xartemis XR is the only extended-release opioid on the market that contains both oxycodone and acetaminophen.
Endo’s Aveed FDA-Approved for Testosterone Replacement
Endo Pharmaceuticals has received U.S. Food and Drug Administration (FDA) approval of Aveed (testosterone undecanoate), a long-acting depot injection for the treatment of male hypogonadism (Low-T). The approval of Aveed, an androgen steroid, is based on data from an 84-week Phase 3 trial of hypogonadal men. Men enrolled in the study were on average 54 years of age with a serum total testosterone level of less than 300 ng/dL. Aveed increased mean serum testosterone levels that were maintained for up to 10 weeks. Aveed is given by intramuscular injection once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter.
Posted: March 2014
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