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Amjevita (adalimumab-atto) Approved

FDA approves Amjevita, a biosimilar to Humira

The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.

Amjevita is approved for the following indications in adult patients:

  • moderately to severely active rheumatoid arthritis;
  • active psoriatic arthritis;
  • active ankylosing spondylitis (an arthritis that affects the spine);
  • moderately to severely active Crohn’s disease;
  • moderately to severely active ulcerative colitis; and
  • moderate to severe plaque psoriasis.

Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Biological products are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

The FDA’s approval of Amjevita is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Amjevita is biosimilar to Humira. It has been approved as a biosimilar, not as an interchangeable product.

The most serious known side effects with Amjevita are infections and malignancies. The most common expected adverse reactions with Amjevita are infections and injection site reactions.

Like Humira, the labeling for Amjevita contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

Amjevita is manufactured by Amgen, Inc., of Thousand Oaks, California. Humira was approved in December 2002 and is manufactured by AbbVie Inc. of North Chicago, Illinois.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

AHFS Patient Medication Information Update – September 2016

The September update to the AHFS Patient Medication Information (PMI) database has been published. Highlights of the update include:

New PMI Monographs:

  • Lifitegrast Ophthalmic (Xiidra®)
    • Ophthalmic lifitegrast is used to treat the signs and symptoms of dry eye disease. Lifitegrast is in a class of medications called lymphocyte function-associated antigen-1 (LFA-1) antagonist. Lifitegrast works by reducing the swelling in the eye tissues.
  • Diphenhydramine Injection (Benadryl®)
    • Diphenhydramine injection is used to treat allergic reactions, especially for people who are unable to take diphenhydramine by mouth. It is used also to treat motion sickness. Diphenhydramine injection is also used alone or along with other medications to control abnormal movements in people who have Parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance).
  • Cabozantinib [advanced renal cell carcinoma] (Cabometyx®)
    • Cabozantinib (Cabometyx) is used to treat advanced renal cell carcinoma (RCC; a type of cancer that begins in the cells of the kidneys) that has worsened after treatment with other chemotherapy medications.

FDA MedWatch Alerts – Monograph Revisions

  • Combined use of opioid and benzodiazepines resulting in slowed or difficult breathing and deaths
    • Affected monographs:
      • Hydrocodone Combination Products, Chlordiazepoxide and Clidinium, Pentazocine, Hydromorphone Injection, Meperidine Injection, Metronidazole Injection, Morphine Injection, Fentanyl Transdermal Patch, Butorphanol Nasal Spray, Buprenorphine Sublingual and Buccal (opioid dependence), Diazepam Rectal, Fentanyl, Morphine Rectal, Tapentadol, Oxymorphone, Clobazam, Fentanyl Nasal Spray, Hydromorphone Rectal, Fentanyl Sublingual Spray, Buprenorphine Transdermal Patch, Hydrocodone, Buprenorphine Buccal (chronic pain), Hydromorphone, Diazepam, Oxazepam, Flurazepam, Clorazepate, Lorazepam, Codeine, Chlordiazepoxide, Meperidine, Oxycodone, Morphine, Methadone, Clonazepam, Butorphanol Injection, Alprazolam, Temazepam, Triazolam, Estazolam, Tramadol

Exondys 51 (eteplirsen) Approved

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

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