Monthly News Roundup - September 2016
Amjevita, a Biosimilar to Humira, Wins FDA Approval
Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the U.S. Food and Drug Administration (FDA) and is used for the treatment of seven inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. Amjevita is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. Amjevita is not approved as an interchangeable product, meaning the pharmacist needs direction from the prescribing doctor to substitute Amjevita for Humira. Common side effects include increased risk of infections and injection site reactions. Amjevita will be commercially available in a prefilled syringe or autoinjector.
Exondys 51 is First Drug Approved for Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy (DMD) is the most common childhood form of muscular dystrophy and is caused by a mutation in the dystrophin gene. This month, the US Food and Drug Administration (FDA) approved Exondys 51 (eteplirsen), specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD. Exondys 51 is classified as a morpholino antisense oligomer, and was approved under FDA accelerated approval pathway for serious or life-threatening diseases. Additional studies will be conducted by Sarepta Therapeutics to fully confirm the drug’s clinical benefit.
FDA Clears Yosprala to Lower Cardiovascular Risk
Once-daily Yosprala (aspirin and omeprazole) from Aralez Pharmaceuticals is now FDA approved for patients who require aspirin for secondary prevention of heart attack or stroke and who are at risk of developing gastric (stomach) ulcers due to aspirin use. Yosprala delivers immediate-release omeprazole (40 mg) followed by a delayed-release, enteric-coated aspirin core in either 81 mg or 325 mg dose strengths. The enteric-coated aspirin dissolves after the stomach pH reaches 5.5 or greater to reduce ulcer risk. Studies have shown that patients who stop cardioprotective aspirin due to a stomach bleed increase their risk of a cardiovascular event or death by almost 7-fold.
Shire Announces FDA Approval of Cuvitru for Primary Immunodeficiency
Primary Immunodeficiency (PI) Syndrome results in a weakened immune system and low levels of immune globulins needed as antibodies. PI can increase a patient’s risk for infections and recovery may be difficult. The FDA has now granted approval for Cuvitru [Immune Globulin (IG) Subcutaneous (Human), 20% Solution] in patients two years of age and older. Cuvitru 20% offers an advantage because a larger volume can be more quickly infused, resulting in fewer number of infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments. Shire expects a U.S. launch of Cuvitru in the coming weeks.
Joint Effort: A Provider's Guide To Orthopedic Pain Options
Orthopedic pain can be multifactorial, and treatment may require several therapies to combine synergistic mechanisms. Opioids for long-term pain relief are becoming less of an option due to addiction, overdose and illegal diversion, and authorities are clamping down on their prescribing. So what non-narcotic medications can a doctor use to ease a patient’s bone pain? Besides NSAIDs, acetaminophen, and muscle relaxants, other options might include antidepressants, anticonvulsants, topical anti-inflammatories and hyaluronic acid derivatives. In this Drugs.com slideshow developed especially for health care providers, review unique pharmacotherapy options, novel treatment tips, and recent opioid guidance.
Posted: September 2016