Pharmaceutical Market Europe • March 2026 • 8
NEWS
J&J’s nipocalimab gets FDA Fast Track designation for lupus
Johnson & Johnson’s (J&J) nipocalimab, a potential immunoselective investigational treatment for adults with systemic lupus erythematosus (lupus), has been granted US FDA Fast Track designation.
The US FDA Fast Track designation programme aims to deliver therapeutics to patients more quickly where unmet needs remain by expediting the development and reviewing timelines of drugs that demonstrate the potential to treat serious conditions.
Lupus is an autoimmune disease disease that affects multiple organs including the skin, joints, kidneys, blood and central nervous systems.
Estimated to impact between three and five million people worldwide, lupus can significantly reduce quality of life.
Associated chronic signs and symptoms include severe fatigue, pain, swelling and rashes. Systemic inflammation, disease flares and reliance on steroids can cause patients to be at risk of irreversible organ damage.
Nipocalimab lowers immunoglobin G (IgG), one of the root causes of autoimmune diseases, while preserving critical immune function.
J&J has started enrolling adults with active SLE in the phase 3 GARDENIA study, after reporting positive results from the phase 2b JASMINE trial, where nipocalimab demonstrated a reduction in disease activity.
PureTech gets FDA and EC Orphan Drug designations for idiopathic pulmonary fibrosis
PureTech Health’s deupirfenidone (LYT-100) has received Orphan Drug Designation to treat idiopathic pulmonary fibrosis (IPF).
The designations were granted by the US FDA and the European Commission (EC) for the treatment of IPF, a rare, progressive and fatal lung disease.
Orphan Drug Designation aims to support the development of therapies for rare diseases, providing sponsors with incentives to develop drugs for diseases with high unmet medical needs.
Rare diseases are defined as conditions affecting fewer than 200,000 people in the US or fewer than five in 10,000 individuals in the EU.
Results from the global phase 2b randomised, double-blind, active- and placebo-controlled, dose-ranging ELEVATE IPF trial underscored the differentiated profile of deupirfenidone.
In that trial, participants treated with deupirfenidone 825mg three times a day (TID) experienced a slower rate of lung function decline at 26 weeks versus those who were treated with the FDA-approved dose of pirfenidone 801 mg TID or placebo.
Deupirfenidone is being advanced by Celea Therapeutics, a Founded Entity established by PureTech to lead its late-stage development and potential commercialisation. A phase 3 trial is planned in 2026.
Diabeloop’s DBLG2 receives FDA and CE clearance for automated insulin delivery without meal input
Diabeloop, a company developing AI-based diabetes management systems, has announced that its DBLG2 has become the first automated insulin delivery system where meal announcements are no longer mandatory to get clearance from the US FDA, as well as a CE mark, for patients with type 1 diabetes.
A lack of meal announcements can potentially lead to lower glycaemic control. However, Diabeloop’s approach has the advantage of giving people living with diabetes greater choice and autonomy.
For people with type 1 diabetes, mealtimes represent one of the most significant challenges.
The constant need to calculate carbohydrate intake, estimate insulin doses and make timely dosing decisions contributes heavily to the mental burden experienced by many individuals.
With DBLG2’s advanced adaptive algorithm, users benefit from an automatic correction mechanism, even when a meal is not announced. This innovation offers a new user experience that prioritises daily quality of life by reducing the cognitive workload associated with diabetes management, although with a potential reduction in glycaemic control compared to fully announced meals.
In December 2025, DBLG2 was granted FDA clearance as a Class II Interoperable Automated Glycemic Controller.