FDA approves Ozempic to treat CKD in diabetes patients; AbbVie, Neomorph ink US$ 1.64 bn deal for molecular glue degraders

By PharmaCompass

2025-01-30

Impressions: 435

Novo Nordisk’s Ozempic became the first glucagon-like peptide 1 (GLP-1) drug to receive the US Food and Drug Administration (FDA) approval for reducing the risk of kidney failure and cardiovascular death in diabetes patients with chronic kidney disease (CKD). The approval could reshape the treatment for millions affected by the condition.

In Alzheimer’s care, FDA has approved a monthly maintenance dose for Eisai and Biogen’s Leqembi, aiming to improve patient adherence by reducing the frequency of administration while maintaining its effectiveness in slowing cognitive decline.

AbbVie has partnered with Neomorph in a US$ 1.64 billion deal to develop molecular glue degraders, an emerging drug class that targets previously “undruggable” proteins for cancer and immune diseases. Meanwhile, Merck and Eisai’s combination therapy of Keytruda and Lenvima has failed to improve survival in gastroesophageal cancer, marking yet another setback for the drug duo.

Psychedelic medicine saw progress as Atai Life Sciences reported encouraging results for its intranasal therapy in alcohol use disorder, showing significant reductions in alcohol consumption and relapse rates.

And the Trump administration had to waive off an executive order that halts the supply of lifesaving drugs for HIV, malaria, tuberculosis to poor countries after lawmakers and medical experts termed it as risky and catastrophic. The “emergency humanitarian waiver”, however, is temporary in nature.

Novo’s Ozempic becomes first GLP-1 drug to win FDA approval to treat CKD in diabetes patients

FDA has approved Novo Nordisk’s Ozempic (semaglutide) to reduce the risk of kidney disease progression, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). This approval makes Ozempic the first GLP-1 receptor agonist indicated for this patient population. CKD, characterized by a gradual decline in kidney function, is a leading cause of mortality in the US, affecting approximately 37 million adults, with about 40 percent of type 2 diabetes patients also experiencing CKD.

Lilly terminates trial on CKD med: Eli Lilly has terminated a mid-stage trial of its investigational therapy volenrelaxin in CKD due to “a lack of foreseeable clinical benefit” in its target CKD population.

Monthly maintenance dosing for Eisai, Biogen’s Alzheimer’s drug approved

FDA has approved a monthly maintenance dosing regimen for Eisai and Biogen’s Alzheimer’s drug, Leqembi (lecanemab-irmb). Initially administered bi-weekly for 18 months, patients can now transition to a 10 mg/kg dose every four weeks. This change aims to maintain effective drug concentrations, sustaining the clearance of amyloid-beta plaques, or proteins linked to Alzheimer’s disease progression. The two companies anticipate that the more convenient dosing schedule will enhance patient adherence and potentially improve the drug’s market performance, which has faced challenges due to its demanding administration requirements. Despite its demonstrated efficacy in slowing cognitive decline, Leqembi’s uptake has been slower than expected, partly due to its demanding administration process including regular MRIs and screenings.

AbbVie, Neomorph forge US$ 1.64 bn partnership to develop molecular glue degraders for oncology, immunology

AbbVie and Neomorph have entered a collaboration to develop novel molecular glue degraders for oncology and immunology. This partnership leverages AbbVie’s drug development expertise and Neomorph’s advanced platform, aiming to target previously “undruggable" proteins. The deal is potentially worth up to US$ 1.64 billion to Neomorph, including upfront payments, option fees, milestones, and royalties on net sales. This collaboration underscores the growing interest in molecular glue degraders. In fact, this is protein-degradation specialist Neomorph’s third major pharmaceutical deal worth over US$ 1.45 billion within a year.

Merck, Eisai's Keytruda combo witnesses another late-stage failure, this time in gastroesophageal cancer

Merck and Eisai announced that their combination therapy of Keytruda (pembrolizumab) and Lenvima (lenvatinib), when used with chemotherapy, did not achieve the primary goal of extending overall survival in patients with advanced gastroesophageal adenocarcinoma in a late-stage trial. While the treatment showed a statistically significant improvement in progression-free survival and objective response rate, it fell short in improving overall survival compared to standard chemotherapy. Previously, the Keytruda-Lenvima combo had failed to meet overall survival endpoints in trials for non-small cell lung cancer, head and neck squamous cell carcinoma, and melanoma.

Atai Life Sciences’ psychedelic therapy posts encouraging results in treating alcohol use disorder

Atai Life Sciences has announced encouraging results from a mid-phase study evaluating BPL-003, an intranasal formulation of 5-MeO-DMT benzoate in patients with moderate to severe alcohol use disorder (AUD). Over a 12-week period, participants who received a single dose of the psychedelic therapy combined with relapse prevention cognitive behavioral therapy saw a significant reduction in alcohol consumption. Additionally, 50 percent of the patients maintained complete abstinence throughout the study duration. The therapy was well-tolerated, with no serious or severe adverse events reported.

Atai Life Sciences plans to further explore the potential of BPL-003 in treating substance use disorders. This comes on the heels of FDA’s approval of J&J’s esketamin e nasal spray, Spravato, as a monotherapy for treatment-resistant depression, signaling growing acceptance of such treatments.

US issues ‘emergency waiver’ after it faces backlash on halting supply of lifesaving meds to poor nations

The Trump administration issued an executive order on January 20 to halt the supply of lifesaving drugs for HIV, malaria, and tuberculosis to poor countries. A memo reviewed by Reuters showed that the administration had begun to stop the medical supplies of these drugs.

This decision sent shockwaves through global health organizations and aid agencies. USAID’s head of global health Atul Gawande called the move “catastrophic”. In a letter addressed to Marco Rubio, Secretary, US Department of State, lawmakers such as Gregory Meeks and Lois Frankel expressed “deep concern over the lives placed at risk” because of the freeze.

“The damage we risk is simply too high,” the letter said. For example, the President’s Emergency Plan for AIDS Relief currently provides 20.6 million people across 55 countries with anti-retroviral treatment for HIV/AIDS. Soon, Rubio approved an “emergency humanitarian waiver” that will allow access to HIV treatment to these patients in 55 countries. UNAIDS welcomed the decision, even though the waiver is temporary in nature.

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : Phisper Infographic by PharmaCompass license under CC BY 2.0

“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

NEWS

DRUGS & DEVELOPMENTS

MARKET INTEL by PharmaCompass