Top 3 Crohn’s Disease, Ulcerative Colitis Treatments Are on the Way

Three promising treatments for Crohn’s disease and ulcerative colitis could be available in the United States in the near future. Here are the top 3 medications — including 2 biosimlars — that offer new treatment options for the diseases.

1. Sandoz said¹ that the FDA has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar Tysabri (natalizumab), developed by Polpharma Biologics. The European Medicines Agency (EMA) also accepted Sandoz’s marketing authorization application (MAA).

The applications include all indications covered by the reference medicine Tysabri for Crohn´s Disease as well as relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease in adults.

“This is the first and only submission for a biosimilar natalizumab medicine in both the United States and Europe. If approved, this biosimilar has the potential to increase access while also delivering savings for healthcare systems,” said Florian Bieber, global head of Biopharmaceuticals Development at Sandoz.

2. Sandoz said² the FDA has accepted for review its Supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz (adalimumab-adaz).

The application includes the indications of the reference medicine Humira (adalimumab) not protected by orphan exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

“Biosimilars play a crucial role in generating billions of dollars of savings for patients and the US health care system every year, while improving healthcare sustainability,” said Keren Haruvi, president of Sandoz Inc., head of North America. “Should the Hyrimoz HCF be approved, we believe this important biosimilar medicine would help expand access to more patients with serious inflammatory diseases, including those who currently may not have access to it.”

Hyrimoz 50 mg/mL was approved by the FDA in 2018.

Sandoz conducted a Phase I pharmacokinetics (PK) bridging study comparing Hyrimoz 50 mg/mL and citrate-free Hyrimoz HCF. “This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz HCF,” the pharma maker said.

3. AbbVie submitted applications for a new indication to the FDA and European Medicines Agency (EMA) for Rinvoq (upadacitinib) to treat adult patients with moderately to severely active Crohn's disease.³

Rinvoq is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases, including rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, giant cell arteritis, and Takayasu arteritis, AbbVie said.

"Crohn's disease can be debilitating and have a significant impact on a person's daily life," said Neil Gallagher, M.D., Ph.D., vice president of development and chief medical officer for AbbVie. "Those patients who are still suffering fuel our continued commitment to innovation in care for patients with inflammatory bowel disease, and we look forward to potentially introducing a new treatment option for this disruptive condition.”

AbbVie’s 3 induction and maintenance studies found that significantly more patients treated with Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response, with clinical remission measured by the Crohn's Disease Activity Index (CDAI) or by the patient-reported symptoms of stool frequency/abdominal pain (SF/AP).

In addition, more patients receiving Rinvoq 45 mg once daily at week 12 in the induction studies or 15 mg and 30 mg once daily at 52 weeks in the maintenance study achieved the secondary endpoint of corticosteroid-free clinical remission per CDAI and per SF/AP compared to placebo among patients taking corticosteroids at baseline.

References

1. Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA. News release. Novartis. July 25, 2022. Accessed August 5, 2022. https://www.novartis.com/news/media-releases/applications-proposed-first-kind-multiple-sclerosis-biosimilar-natalizumab-accepted-us-fda-and-ema
2. Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF). News release. Novartis. July 21, 2022. Accessed August 5, 2022. https://www.novartis.com/news/media-releases/sandoz-supplemental-biologics-license-application-accepted-us-fda-biosimilar-hyrimoz-adalimumab-adaz-high-concentration-formulation-hcf
3. AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) in Crohn's Disease. News release. AbbVie. July 27, 2022. Accessed August 5, 2022. https://news.abbvie.com/news/press-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-upadacitinib-rinvoq-in-crohns-disease.htm