On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).  The filing is supported by data from the Phase 3 ASTRO study (NCT05528510).

This follows the recent approval of Tremfya® in the US for UC, with an intravenous induction dose followed by subcutaneous maintenance (September 2024).  Tremfya® is also under consideration for approval for UC in Australia and Europe.

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the months of August, September and October.

Among the new applications to be reviewed is Freyr’s new application for liraglutide (Lobezyl®).  This follows TGA acceptance of Cipla’s liraglutide for review in October 2023 and Sun Pharma’s in January 2024.  Novo Nordisk’s Saxenda® (liraglutide) was approved in Australia in 2015 for weight management.

Meanwhile, an application for a new indication for Novo Nordisk’s Ozempic® (semaglutide), for reducing risk of kidney failure, was accepted for review in September 2024.

Applications for new indications for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) have also been accepted for review (in October and September 2024, respectively), for the treatment of advanced hepatocellular carcinoma or hepatocellular carcinoma that cannot be removed surgically.

AstraZeneca has two applications for expanded indications under review: Imfinzi® (durvalumab) for the treatment of patients with limited-stage small cell lung cancer; and Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with metastatic NSCLC or NSCLC that cannot be removed surgically.

Other applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:

• Janssen’s Tremfya® (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis or Crohn’s disease;
• Eli Lilly’s Omvoh® (mirikizumab) for the treatment of ulcerative colitis in adults who have not benefited from conventional treatments; and
• Roche’s Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

On 28 October 2024, Johnson & Johnson (J&J) announced that its Phase 3 GRAVITI study of Tremfya® (guselkumab) in moderately to severely active Crohn’s disease showed “robust” results in subcutaneous induction and maintenance therapy, demonstrating “significant” clinical remission and endoscopic response at 48 weeks.  Based on these results, J&J considers that guselkumab could become the first IL-23 treatment to offer both SC and IV induction options for Crohn’s disease.

In a separate Phase 3b study (SPECTREM), sponsored by J&J, Tremfya® was shown to result in clear or almost clear skin in the majority of patients with low body surface area moderate plaque psoriasis with special site involvement who had failed topical treatment.  These results were presented on 25 October at the 2024 Fall Clinical Dermatology Conference.

Tremfya® is approved in Europe, the USA and other countries for moderate to severe plaque psoriasis and active psoriatic arthritis.  Tremfya® received FDA approval in September 2024 for moderately to severely active ulcerative colitis.  J&J submitted applications for approval of Tremfya® for Crohn’s disease to the FDA in June 2024 and in Europe in May 2024.

Following a March 2024 sBLA submission, and the successful results of a phase 3 study reported in May 2024, the FDA has approved Johnson & Johnson’s Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Tremfya® is already approved in the US for adults with moderate-to-severe plaque psoriasis and with active psoriatic arthritis.  A further sBLA for Crohn’s Disease was submitted to the FDA in June 2024.

On 21 May 2024, Johnson & Johnson announced results of the GALAXI 2&3 clinical studies of patients with moderate to severe Crohn’s Disease (CD).  The study, sponsored by Janssen Research & Development, showed that Tremfya® (guselkumab) resulted in significant improvements on a number of endoscopic endpoints when compared to both Stelara® (ustekinumab) and placebo.

As previously reported, J&J is seeking EMA approval to expand its marketing authority for Tremfya® to include treatment of adult patients with moderate to severe UC and moderate to severe CD.

On 20 May 2024, Johnson & Johnson announced results of the QUASAR Maintenance Study of patients with moderate to severe ulcerative colitis (UC).  The study, sponsored by Janssen Research & Development, showed that a significantly higher percentage of patients receiving Tremfya® (guselkumab) achieved clinical remission at 44 weeks compared to placebo-treated patients.   

Tremfya® is currently approved in the US and Europe for treatment of severe plaque psoriasis and psoriatic arthritis.  In March 2024, Johnson & Johnson submitted an sBLA to the FDA for Tremfya® for moderately to severely active ulcerative colitis.  This is part of a strategy to expand into inflammatory bowel disease indications. 

On 01 May 2024, Johnson & Johnson announced that it submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorisation for Tremfya® (guselkumab) to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.  This follows news of its US sBLA submission on 11 March 2024 for guselkumab for the treatment of moderately to severely active ulcerative colitis.

Tremfya® (guselkumab) is approved in Europe for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

On 11 March 2024, Johnson & Johnson announced that it submitted a supplemental Biologics License Application (sBLA) for TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis.  The product is currently approved in the US to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis.

Janssen published data from Ph III trials of Tremfya® (guselkumab) for the treatment of psoriatic arthritis.  Janssen reported that early skin and enthesitis responses predicted longer-term clinical response, including disease remission at week 52.

Janssen published data from its Ph IIa clinical trials of guselkumab with golimumab in the treatment of ulcerative colitis.  Janssen reported that adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a higher clinical remission rate than induction and maintenance treatment with either guselkumab alone or golimumab alone.