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Four new treatments approved as NICE issues landmark decisions

Written by | 5 Jun 2026 | Pharma News

The National Institute for Health and Care Excellence (NICE) has issued six Technology Appraisal decisions between 6 and 20 May 2026, recommending four new treatments for NHS use while terminating two further appraisals. The positive decisions span oncology, neurology, cardiovascular medicine, and immunology, and are expected to benefit patients across a range of serious and often life-limiting conditions.

The decisions represent a significant fortnight of activity for the appraisals programme, with treatments for both common conditions — including obesity and lung cancer — and rare diseases receiving consideration.

Wegovy approved for obesity and cardiovascular disease

In arguably the most widely anticipated of the batch, NICE has recommended semaglutide — marketed as Wegovy by Novo Nordisk — for adults living with obesity who also have established cardiovascular disease. The once-weekly injection was approved on 7 May 2026.

The decision extends the clinical indication for Wegovy beyond weight management alone, reflecting a growing body of evidence that semaglutide confers meaningful cardiovascular benefit. The treatment belongs to the GLP-1 receptor agonist class and has attracted substantial clinical and public interest since its introduction for weight loss. This approval is expected to widen NHS access for a subset of patients who carry the greatest cardiometabolic risk.

Rystiggo approved for myasthenia gravis

On 20 May 2026, NICE issued a positive recommendation for rozanolixizumab (Rystiggo), developed by UCB, for the treatment of generalised myasthenia gravis in adults. The condition is a rare chronic autoimmune disorder of the neuromuscular junction, characterised by fluctuating muscle weakness that can affect breathing and swallowing.

Rozanolixizumab works by inhibiting the neonatal Fc receptor (FcRn), thereby reducing circulating levels of the IgG antibodies that drive the autoimmune attack on the neuromuscular junction. The approval addresses a condition with historically limited treatment options beyond long-established immunosuppressive therapies.

Braftovi and Mektovi approved for lung cancer

NICE approved the combination of encorafenib (Braftovi) and binimetinib (Mektovi), produced by Pfizer and Pierre Fabre, for adults with BRAF V600E mutation-positive non-small cell lung cancer (NSCLC) on 6 May 2026. The decision applies to patients who have received at least one prior line of therapy.

Encorafenib is a BRAF inhibitor while binimetinib inhibits MEK, a protein downstream in the same signalling pathway. Combining both agents aims to improve tumour response and delay the development of resistance — a recognised limitation of single-agent BRAF inhibition. NSCLC is the most common form of lung cancer in the United Kingdom, and the BRAF V600E mutation, while relatively rare in this setting, identifies a distinct patient population who may derive particular benefit from targeted therapy.

Ziihera approved for rare bile duct cancer

Zanidatamab (Ziihera), developed by BeOne Medicines in partnership with Jazz Pharma, received a positive recommendation on 7 May 2026 for HER2-positive biliary tract cancer. This rare malignancy affecting the bile ducts and gallbladder carries a poor prognosis, particularly in the relapsed or refractory setting.

Zanidatamab is a bispecific antibody targeting two distinct epitopes of the HER2 receptor, a mechanism that may confer enhanced anti-tumour activity compared with conventional HER2-directed therapies. The approval offers a new targeted option to patients with limited alternatives following prior treatment.

Two appraisals terminated

Not all decisions resulted in positive outcomes. NICE terminated the appraisal of inebilizumab (Uplizna), submitted by Horizon Therapeutics and Amgen, for immunoglobulin G4-related disease (IgG4-RD) on 6 May 2026. IgG4-RD is a chronic fibroinflammatory condition that can affect multiple organ systems and has few approved therapies. The reasons for termination were not specified in the available data.

A further appraisal — for an intravesical formulation of oxybutynin hydrochloride (Vesoxx), submitted by Farco-Pharma GmbH for neurogenic detrusor overactivity — was also terminated on 7 May 2026. Neurogenic detrusor overactivity causes involuntary bladder contractions and is commonly seen in patients with spinal cord injury or neurological disease. While oral oxybutynin is already in widespread use, this submission concerned a novel intravesical route of administration.

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