IBD Therapies: New FDA Approvals

Goals

To obtain a list of new inflammatory bowel disease (IBD) therapies approved in the US 2019-2020 & their indications, side effects & contraindications.

Early Findings

Avsola (infliximab-axxq)

According to the FDA, this is a biosimilar to Remicade (infliximab) and was approved for "a variety of uses including " Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis."
  • Indications: A press release from Amgen states that AVSOLA™ (infliximab-axxq) was approved in Dec. 6, 2019 for the following indications related to Crohn's Disease:
- Crohn's Disease:
1) "reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. " and
2) "reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease."

- Pediatric Crohn's Disease
"for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy."
  • Contraindications: patients with "moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. AVSOLA should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue AVSOLA if new or worsening CHF symptoms appear. AVSOLA should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product."
  • Side effects: the article states that the most common adverse reaction observed in clinical trials of infliximab products "occurring in >10% of patients included infections (e.g., upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain."

Hadlima (adalimumab-bwwd) and Abrilada (adalimumab-afzb)

The FDA states that these are the fourth and fifth biosimilars to Humira (adalimumab) and are " tumor necrosis factor (TNF) inhibitors that suppress the immune system. They are approved for a variety of uses, including rheumatoid arthritis, juvenile idiopathic arthritis in patients 4 years and older, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis."

Hadlima (adalimumab-bwwd)
An article from Biospace states that this biosimilar was approved on July 24, 2019
  • Indications: (Adult Crohn’s Disease) "reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s Disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products."
  • Contraindications: there are no contraindications.
  • Side effects: the most common adverse reactions observed in ">10% include infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash."
Abrilada (adalimumab-afzb)
A press release from Optum shows that this biosimilar was approved on November 18, 2019.
  • Indications: (for Adult Crohn’s Disease) "reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s Disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products."
  • Contraindications: According to the FDA, there are no contraindications.
  • Side effects: the most common adverse reactions observed in "> 10% with Abrilada use were infections (eg, upper respiratory, sinusitis), injection site reactions, headache and rash."


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