The U.S. Food and Drug Administration (FDA) issued some important approvals and updates over the past month. Express Scripts’ Emerging Therapeutic team highlights key updates:
FDA Approves Erelzi, a biosimilar to Enbrel
On Aug. 30, 2016, FDA approved Sandoz’s Erelzi™ (etanercept – szzs), a biosimilar to Amgen’s Enbrel®. Erelzi was approved for all Enbrel-approved indications. It can be used for treating patients with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. The dose of Erelzi varies depending on the indication. While Sandoz’s launch plans for Erelzi are unknown, it is possible that launch could be delayed two years or more due to patent litigation. For full prescribing information, click here.
Exondys 51 Approved for Duchenne Muscular Dystrophy
Under its accelerated approval process, the FDA approved Exondys 51™ (eteplirsen) injection on Sep. 19, 2016. Exondys 51 is the first FDA-approved drug indicated to treat patients who have Duchenne muscular dystrophy (DMD). It specifically is for patients that have been confirmed to have mutations of dystrophin genes amenable to exon 51 skipping. It is given once every week as an intravenous (IV) infusion at 30mg/kg of body weight. Single-use vials contain 50mg/mL in either 2mL or 10mL sizes. Sarepta plans on launching Exondys 51 immediately. Click here for complete prescribing information.
FDA Approves Amjevita, a biosimilar to Humira
On Sep. 23, 2016, the FDA approved Amgen’s Amjevita™ (adalimumab – atto), a biosimilar to AbbVie’s Humira®. Amjevita is approved for treating adults with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. It is also approved for treating children four years of age and older with polyarticular juvenile idiopathic arthritis. The dose of Amjevita varies depending on the indication. While Amgen’s launch plans for Amjevita are unknown, it is possible that launch could be delayed for several years due to patent litigation. Full prescribing information is available here.
Stelara Approved for Crohn’s Disease
The FDA authorized an additional indication for Janssen Biotech’s Stelara® (ustekinumab) on Sep. 23, 2016. Stelara, a monoclonal antibody that targets interleukins 12 and 23 (IL-12 and IL-23), is already FDA approved for treating psoriasis and psoriatic arthritis. Its new indication is to treat adults who have moderate to severe active Crohn’s disease that has not responded to corticosteroids, immunomodulators or tumor necrosis factor (TNFα) inhibitors. A first dose of up to 520mg is determined by the weight of the patient and infused intravenously (IV) by a healthcare provider. Then, beginning eight weeks after the initial dose, recommended dosing is 90mg of Stelara subcutaneously once every eight weeks. A Medication Guide dispensed with each prescription informs patients and caregivers how to use pre-filled syringes for giving the injections. Updated prescribing information is available here.
Generic Launched for Epzicom
On Sep. 28, 2016, Teva Pharmaceutical Industries introduced to the U.S. market a generic for the combination drug, Epzicom® (abacavir/lamivudine). Taken once daily, it is indicated for use along with other antiretroviral drugs for treating HIV-1 infection in adults and children who weigh at least 25Kg (55 pounds). Each tablet contains 600mg of abacavir and 300mg of lamivudine. Both are nucleoside reverse transcriptase inhibitors (NRTIs). Labeling carries a boxed warning about the drug’s potential to cause hypersensitivity reactions, lactic acidosis and hepatomegaly. It also may worsen hepatitis B for co-infected patients who take it. The status of additional generics is not yet known.
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