Several new drugs and vaccines are anticipated to significantly impact community pharmacy practice in 2025, offering novel therapeutic options for a range of conditions from diabetes to infectious diseases.
Insulin Icodec: A Once-Weekly Basal Insulin for Diabetes Management
Novo Nordisk's insulin icodec (Awiqli, LAI 287) is a once-weekly subcutaneous injection of basal insulin analog designed for treating type 1 and type 2 diabetes. The phase 3 ONWARDS trials evaluated its efficacy, demonstrating positive safety and efficacy data. Specifically, ONWARDS 1 showed a greater reduction in HbA1c at week 52 from baseline in insulin-naïve adults with type 2 diabetes treated with insulin icodec compared to those treated with insulin glargine. Notably, the rates of hypoglycemia were statistically insignificant compared to other insulin analogs throughout the ONWARDS program. While the FDA issued a complete response letter in July 2024 requesting additional data, Novo Nordisk anticipates a US launch later in 2025. The convenience of weekly dosing may improve patient adherence.
CagriSema: A Dual-Action Approach to Obesity and Type 2 Diabetes
Cagrilintide and semaglutide (CagriSema; Novo Nordisk) is a fixed-dose combination of a GLP-1 receptor agonist (semaglutide) and a long-acting amylin analog (cagrilintide), administered once weekly via subcutaneous injection for obesity and type 2 diabetes. This combination leverages distinct hormonal pathways to achieve blood glucose control and weight loss. In a phase 2 clinical trial, the combination resulted in significant weight loss reduction in patients with type 2 diabetes, demonstrating superiority to both cagrilintide and semaglutide alone. The REDEFINE 1 phase 3 trial further confirmed superior weight loss in adults with obesity or overweight compared to either drug alone or placebo. While US launch for obesity is expected in 2026 and for T2D in 2028, CagriSema holds promise as a more effective obesity medicine compared to existing GLP-1s.
Lebrikizumab: A Novel Biologic for Atopic Dermatitis
Eli Lilly and Co's lebrikizumab (Ebglyss) is a subcutaneous injection for adults and children (12+ years, >=88 lbs) with moderate-to-severe atopic dermatitis. Administered every two weeks initially, followed by monthly maintenance, it targets interleukin-13. The FDA approved lebrikizumab in September 2024 for inadequately controlled atopic dermatitis despite topical therapies. The phase 3b ADapt trial showed improved itch relief in patients previously treated with dupilumab (Dupixent; Sanofi, Regeneron). Other phase 3 trials (ADvocate 1, ADvocate 2, ADhere) have also indicated its effectiveness in adults and children with moderate-to-severe eczema.
GSK-3536819: A Pentavalent Meningococcal Vaccine
GSK's GSK-3536819 is a recombinant protein, conjugated, pentavalent vaccine targeting the five Neisseria meningitidis groups (A, B, C, W, and Y) responsible for meningococcal disease. Administered as a two-dose intramuscular injection six months apart to individuals aged 10-25 years, it combines components of GSK's existing meningococcal vaccines (Bexsero and Menveo). This vaccine aims to provide comprehensive protection against the most invasive meningococcal disease globally and reduce the burden of multiple injections. The FDA accepted GSK's biologics license application (BLA) in April 2024 based on positive phase 3 MenABCWY trial results, with a PDUFA action date of February 14, 2025.
mRNA-1345 (mRESVIA): An mRNA Vaccine for RSV
Moderna's mRNA-1345 (mRESVIA) is a single, 0.5-mL intramuscular injection for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older. The vaccine utilizes an mRNA sequence encoding a stabilized prefusion F glycoprotein and was FDA-approved in May 2024. The approval was based on the ConquerRSV phase 3 clinical trial, which demonstrated an efficacy of 83.7% against RSV-LRTD with two or more symptoms. The Advisory Committee on Immunization Practices (ACIP) recommends its use in all adults 75 and older and in adults aged 60-74 at increased risk of severe RSV disease.
SEL-212: A Novel Treatment for Chronic Refractory Gout
SEL-212 (Sobi, Cartesian Therapeutics) combines nanoparticles encapsulating sirolimus and pegylated uricase for once-monthly intravenous infusion to treat chronic refractory gout. This combination addresses limitations of current gout treatments, such as reduced efficacy and tolerability due to anti-drug antibodies. By reducing serum urate levels, SEL-212 minimizes tissue urate deposits that can lead to gout flares and joint deformity. It received FDA fast track designation in March 2024, and a rolling BLA was submitted in July 2024 based on positive phase 3 DISSOLVE study results. Launch is expected in 2025, offering a more effective treatment option for patients with gout.
