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The US Food and Drug Administration (FDA) has granted traditional approval for Eisai and Biogen’s Leqembi (lecanemab-irmb) 100mg/mL injection to treat Alzheimer’s disease (AD) in adults.

With the approval of the supplemental biologics licence application (sBLA), Leqembi becomes the first therapy to slow disease progression rate and cognitive and functional decline in AD patients.  

This development is based on findings from the Phase III portion of Eisai’s Clarity AD clinical trial.

Trial data showed that the product met the Leqembi primary endpoint and all crucial secondary endpoints, and also demonstrated clinical benefit. In January 2023, the regulatory agency granted accelerated approval for Leqembi.

Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody that targets aggregated soluble (protofibril) and amyloid beta’s (Aβ) insoluble forms.

The US Department of Health and Human Services (HHS) has announced a set of actions to reduce healthcare costs.

US President Joe Biden’s Inflation Reduction Act (IRA) includes measures to reduce the price of certain drugs prescribed to senior citizens and people with disabilities.

The HHS has also introduced updated drug price negotiation guidance from the Centers for Medicare & Medicaid Services (CMS).

The guidance is a vital step in executing the IRA’s strategy, which will enable Medicare to negotiate lower drug prices for those receiving its services. From 2023, Medicare will begin negotiating directly with drug manufacturers to reduce the rate of the high-priced prescription drugs its policies cover.

CMS will reveal the first ten drugs selected for negotiation by 1 September. The first round of discussions will take place in 2023 and 2024 with the reduced prices effective from 2026.

NorthX Biologics has acquired Valneva’s clinical trial manufacturing unit in Stockholm, Sweden. The takeover comprises the transfer of a multi-purpose site with 30 staff, located in the Stockholm life sciences cluster. 

The staff and facility have a long history of experience in internal services, contractual development and production activities with external clients. Their capabilities in mammalian expression systems and viral vectors complement the expertise of NorthX’s existing business of sophisticated microbial-based protein and plasmid deoxyribonucleic acid (DNA) production.  

The acquired unit possesses expertise in process development, GMP manufacturing, ramp-up, quality assurance/release and control analytics. It can also handle biosafety level (BSL) 2/2+ and BSL 3 organisms. This acquisition will support NorthX in bolstering its expertise and providing complete services to a global client base. Valneva Sweden managing director Janet Hoogstraate will become part of NorthX following the deal’s closure.

The US FDA has approved a label update for Leqvio (inclisiran) as an adjunct treatment with diet and statins for patients with primary hyperlipidaemia. The patient population includes those without a cardiovascular event and comorbidities like hypertension and diabetes. 

Hyperlipidaemia is characterised by elevated levels of low-density lipoprotein cholesterol (LDL-C), which then accumulate in the arterial lining as plaques. These plaques can rupture and cause heart attack or stroke. The patient population includes those without a cardiovascular event and comorbidities such as hypertension and diabetes. 

In December 2021, Leqvio was initially approved by the FDA for treating atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH). The company reported patients having 52% lower LDL-C with Leqvio, the small interfering RNA (siRNA) therapy, versus placebo in a patient group that was unable to reach their LDL-C target despite statin therapy.

The European Medicines Agency (EMA) is reviewing data on the potential effects of high-profile glucagon-like peptide-1 receptor agonists (GLP-1RAs), including Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) in causing suicidal thoughts and thoughts of self-harm.

The EMA has previously approved these drugs for weight loss and/or as treatments for type 2 diabetes. The EMA investigation comes after the Icelandic Medicines Agency flagged reports of suicidal thoughts and self-injury in patients taking Ozempic and Saxenda. Authorities are so far investigating 150 reports of possible cases of self-injury and suicidal thoughts.

Led by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA evaluation aims to find if these symptoms are linked to the medicines themselves, are unrelated or caused by other underlying factors. The EMA reports that more than 20 million patients in the EU have so far used liraglutide and semaglutide.