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FDA Approves HADLIMA, RINVOQ for Arthritis

August 16, 2019
Two new drugs enter the US market.

A PPM Brief

HADLIMA Approved for Various Arthritic Conditions

Samsung Bioepis (Incheon, South Korea) has announced1 FDA approval of HADLIMA (adalimumab) for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. HADLIMA is the company’s third anti-tumor necrosis factor (TNF) biosimilar approved for marketing in the US, set to be commercialized by Merck (Kenilworth, NJ) and expected to launch in the US in June 2023, in accordance with a licensing agreement with AbbVie (North Chicago, IL).

“We believe the US healthcare system can benefit from biosimilars, as they could play an important role in broadening access to treatment options for patients with autoimmune conditions,” said Hee Kyung Kim, senior vice president of Samsung Bioepis, in a company release.

The approval was based on several studies, including a randomized, double-blind, 52-week Phase 3 study. Approximately 544 patients with moderate to severe RA were randomized to receive either HADLIMA or an adalimumab reference product (ADL).

Phase 3 results indicated that:

  • At 24 weeks, the American College of Rheumatology 20 criteria (ACR20) response rate was 72.4% in the HADLIMA group vs 72.2% in the ADL group.
  • The safety profile of HADLIMA was comparable to ADL at 24 weeks.

After 24 weeks, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transition to HADLIMA (patients receiving HADLIMA continued to receive HADLIMA). After Week 52, the efficacy and safety profiles remained comparable between all three treatment groups.

In addition to the US, HADLIMA is currently approved for marketing in 28 EU member states, Canada, Australia and Korea.

FDA Approves Samsung Bioepis' HADLIMA (adalimumab-bwwd) (Source: 123RF)

TNF inhibitors are a group of medications that reduce inflammation and stop disease progression. In those who have rheumatic conditions, higher levels of TNF in the blood lead to more inflammation and persistent symptoms. These medications can alter a disease’s effect on the body by controlling inflammation in the joints, gastrointestinal tract, and skin.

Currently, TNF inhibitors approved by FDA for the treatment of rheumatic diseases include:

  • Adalimumab (Humira)
  • Adalimumab-adbm (Cyltezo), a biosimilar to Humira
  • Adalimumab-adaz (Hyrimoz), a biosimilar to Humira
  • Adalimumab-atto (Amjevita), a biosimilar to Humira
  • Certolizumab pegol (Cimzia)
  • Etanercept (Enbrel)
  • Etanercept-szzs (Ereizi), a biosimilar to Enbrel
  • Golimumab (Simponi, Simponi Aria)
  • Infliximab (Remicade)
  • Infliximab-abda (Renflexis) a biosimilar to Remicade
  • Infliximab-dyyb (Inflectra), a biosimilar to Remicade

AbbVie Receives Approval

RINVOQ (upadacitinib), from AbbVie (North Chicago, IL), has received FDA approval2 for the treatment of moderate to severe RA in adults. A 15 mg, once-daily oral Janus kinase (JAK) inhibitor, the drug is used primarily in patients who have had an inadequate or intolerant response to methotrexate (MTX-IR).

Approval was based on results from the SELECT program, with 4,400 patients evaluated in five studies. The studies included assessments of efficacy, safety, and tolerability across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs (DMARDs) and those who were naïve or were inadequate responders to MTX-IR (RINVOQ is not indicated for MTX-naïve patients). Over the course of the program:

  • 52% of MTX-naïve patients treated with RINVOQ 15 mg achieved ACR50 vs 28% treated with MTX at week 121
  • 68% of MTX-IR patients treated with RINVOQ 15 mg achieved ACR20 vs 41 percent treated with continued MTX at week 141
  • 71% of MTX-IR patients treated with RINVOQ 15 mg plus MTX achieved ACR20 vs 36% treated with placebo plus MTX at week 121
  • 64% of csDMARD-IR patients treated with RINVOQ 15 mg plus csDMARDs achieved ACR20 vs 36% treated with placebo plus csDMARDs at week 121
  • 65% of biologic-IR patients treated with RINVOQ 15 mg plus csDMARDs achieved ACR20 vs 28% treated with placebo plus csDMARDs at week 121

Rinvoq is expected to be available in the US in late August 2019. Rinvoq is currently being reviewed by the European Medicines Agency (EMA), as well as regulatory authorities in Canada and Japan.

Last updated on: August 22, 2019
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