FDA Updates for the Week of Nov. 20, 2023
FDA has approved a new therapy for HR positive breast cancer and announces plan to hold advisory meeting for Abecma in earlier treatment of multiple myeloma. In addition, Janssen has submitted a supplemental application for Rybrevant in NSCLC.
Clinical Trial Begins of Gene Therapy for Parkinson-Like Disease
A new gene therapy administered directly to the brain aims to preserve dopamine neurotransmission in patients with multiple system atrophy.
CVS Removes Biosimilars from Drug List
One notable change: CVS Caremark has removed the Humira biosimilar Amjevita and now prefers Hyrimoz and an unbranded biosimilar.
Study Finds Beovu and Eylea Achieve Similar Visual Improvements in Macular Edema
Beovu led to greater improvement in retinal thickness and reduction of retinal fluid in patients with diabetic macular edema, a secondary endpoint in this head-to-head trial.
Express Scripts’ New Option Models Mark Cuban’s Cost Plus Drugs
This is the latest offering by Express Scripts that aims to bring transparency to prescription drug costs.
Newest Psoriasis Treatment is Now Available
Bimzelx is the first dual IL-17 A/F inhibitor to treat moderate-to-severe plaque psoriasis. It launches with a list price of $7,200 per syringe.
Optum Rx Makes Formulary Changes for 2024
First in class, biosimilars, oncology drugs and even some generics have been added to Optum Rx’s list of exclusions for 2024.
Benefit of Inpefa in Heart Failure Seen at 3 Months | AHA Scientific Sessions
A post-hoc analysis of the SCORED clinical trial identified early benefit for patients taking Inpefa in both heart failure and major adverse cardiovascular events (MACE) related outcomes
Inpefa Decreases Hospitalizations and Lowers Costs | AHA Scientific Sessions
An analysis estimated the clinical and economic impact of Inpefa using inputs from a phase 3 trial of the heart failure drug.
Investigational Monoclonal Antibody Reduces Stroke Risk with Less Bleeding | AHA Scientific Sessions
In a phase 2 trial, abelacimab achieved a 99% inhibition of Factor XI and a 67% reduction in major or clinically relevant non-major bleeding events.
Farxiga Shows Benefit for Those with Myocardial Infarction | AHA Scientific Sessions
A study with a unique trial design and a newer endpoint shows Farxiga can improve cardiometabolic outcomes in a subset of patients.
FDA Approves New Weight Loss Drug
Tirzepatide, with the brand name Zepbound, is expected to be available by the end of the year in six doses at a list price of $1,059.87, which is about 20% lower than semaglutide.
Precision Medicine Comes to Ocular Oncology | AAO 2023
Precision medicine will lead to fewer cases of ocular cancers, earlier diagnosis, and more targeted and sight-saving treatments.
Managing the Adverse Events in Patients Treated with Tepezza | AAO 2023
In real-world experience, Tepezza benefits patients with moderate-to-service thyroid eye disease, but adverse events can lead to discontinuation.
Glaucoma is Undertreated Among Minorities | AAO 2023
Racial disparities in glaucoma care persist, regardless of socioeconomic status, finds new research presented at the annual meeting of the American Academy of Ophthalmology.
Gene Therapy Shows Potential for Diabetic Macular Edema | AAO 2023
In a late breaking session, a one-time gene therapy was found in a phase 2 trial to provide sustained release of dexamethasone in patients with diabetic macular edema and retinal vein occlusion. The trial is ongoing.
Medicare Payments for Retinal Procedures are Down | AAO 2023
Innovations have allowed retinal procedures to be completed more rapidly with better patient outcomes. One speaker at AAO argues, however, that reimbursement should also consider the complexity of the procedure and not just the time it to takes to complete.
AI-Generated Eye Care Information Not Accurate | AAO 2023
Researchers caution that popular chatbots, while having the potential to improve access and quality of patient education, provide unreliable medical advice.
ICER Found Plans Provided Fair Access, But Greater Transparency of Policies is Needed
The Institute for Clinical and Economic Review’s fair access report found that it was difficult to determine how well policies translate into real-world access and affordability for patients.
Elevidys Misses Primary Endpoint, but Shows Evidence of Modifying the Course of Duchenne
Sarepta Therapeutics plans to submit an application for full approval of Elevidys to treat all ages of patients with Duchenne muscular dystrophy. Company officials said the FDA is open to evaluating the application based on the totality of the evidence.
Lebrikizumab Maintains Skin Clearance for Two Years in Atopic Dermatitis
Almost 80% of patients in an extension study maintained clear or almost clear skin, and 90% of patients saw continued improvements in itch.
FDA Approves First-in-Class Therapy for Ulcerative Colitis
Mirikizumab — now with the brand name — Omvoh is the first therapy that targets interleukin-23p19, which plays a role in inflammation. It has a list price of $9,593 per month for the IV formulation and $10,360 per subcutaneous administration.
Gene Therapy for Rare Immune Disorder Gets FDA Review Date
RP-L201 (marnetegragene autotemcel) is a one-time gene therapy that delivers a functional copy of the ITGB2 gene, which provides instructions for immune response to infections. The Prescription Drug User Fee Act (PDUFA) target action date is March 31, 2024.
Study Highlights Role of IL-31 and Itching in Chronic Liver Disease
New results demonstrate seladelpar can reduce alkaline phosphatase and itching in patients with primary biliary cholangitis, a chronic liver disease.
Zymfentra, the First Subcutaneous Infliximab, is Approved by FDA
Celltrion’s Zymfentra is subcutaneous version of infliximab.
Yale Receives NIH Grant to Research Gene Editing Delivery System
Researchers at the Yale School of Medicine have invented a new delivery technology that has the potential to create one-time treatments for a range of neurological disorders.
The Oncology Pipeline Is Delivering Exciting New Treatments — and Sticker Shock | AMCP Nexus 2023
Research continues to develop new therapies for rare cancers and to provide options that allow for fewer toxicities. At the same, however, more new drugs are launching with high price tags.
Magellan’s AI-Assisted Program Saved up to $4,300 PMPY | AMCP Nexus 2023
Using an AI platform, Magellan Health was able to better support providers in prescribing behavioral health medications and addressing medication problems, which reduced pharmacy costs and increased adherence.
Is Home-Based CAR-T Therapy Possible? | AMCP Nexus 2023
The results of a recent feasibility study on the outpatient administration of cell therapies is creating growing interest in whether home-based management may be possible in the future.
Subcutaneous IBD Drugs Could Tip Sizable Chunk of Drug Spend to the Pharmacy Benefit | AMCP Nexus 2023
In her review of the specialty drug pipeline, Evernorth's Aimee Tharaldson said upcoming approvals for Crohn’s and colitis drugs could further shift the drug spend from the medical benefit to the pharmacy one.
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