MPR Weekly Dose

Recent regulatory and clinical developments include the approval of Weltruza — the first once-monthly subcutaneous long-acting formulation of olanzapine for schizophrenia — as well as the first subcutaneous therapy for thyroid eye disease and Hovilpri for refractory mucocutaneous HSV. In addition, the FDA expanded Tecentriq’s reach with newly approved regimens, while Vanda Pharmaceuticals reported...

New FDA approvals for Juvmo in Parkinson disease and Camzyos in pediatric obstructive hypertrophic cardiomyopathy, a Priority Review green light for fenebrutinib in MS, and the sudden BLA withdrawal for a key lung cancer candidate. Hosted by Simplecast, an AdsWizz company. See https://pcm.adswizz.com for information about our collection and use of personal data for advertising.

Results for weight loss treatment combo cagrilintide and semaglutide; positive results for treatment of rare form of ALS, and for sefaxersen in adults with primary IgA nephropathy; gene therapy approved for Sanfilippo syndrome; and Lyrfigtu gains approval for FGFR2+ advanced cholangiocarcinoma.

Approvals for spinal muscular atrophy and chronic kidney disease; Joenja gains expanded approval in APDS; LSD derivative earns Breakthrough status to treat major depressive disorder; and zasocitinib is granted Priority Review for psoriasis.

First treatment approved for Alexander disease; Hyrnuo and Etcamah are approved for lung cancer and breast cancer, respectively; Pelacarsen misses endpoint in the phase 3 HORIZON trial, and atogepant shows promise from relieving menstrual migraines.   

Mounjaro approval expanded to reduce the risk of major cardiovascular events; The American Academy of Pediatrics has issued updated recommendations for RSV immunization; BTK inhibitor shows promise in relapsing MS; and The FDA adds a boxed warning to Injectafer.

Mounjaro approval expanded to reduce the risk of major cardiovascular events; The American Academy of Pediatrics has issued updated recommendations for RSV immunization; BTK inhibitor shows promise in relapsing MS; and The FDA adds a boxed warning to Injectafer.

In a special episode of the MPR Weekly Dose podcast, Dr William Schaffner — professor of preventive medicine and infectious diseases at Vanderbilt University School of Medicine and former CDC Epidemic Intelligence Service officer — discusses the clinical rollout of mFlusiva, the newly-approved mRNA-based influenza vaccine. Dr Schaffner breaks down how this modern platform differs from traditional...

Moderna's mRNA influenza vaccine gains FDA approval; approvals for prostate cancer, narcolepsy type 1 and Mucinex 12HR; and peanut allergy treatment gains Fast Track status.

An over-the-counter acetaminophen/naproxen sodium fixed-dose tablet gains approval; Simtriyo approved for ADHD; Xocova approved for COVID-19 postexposure prophylaxis; A new contraceptive patch is approved; and Furoscix ReadyFlow approval is expanded to treat edema in CHF, CKD.

Kalshi start clinical trials, FDA approvals prediction market; positive results shared for triple hormone therapy retatrutide; Jideytro gains approval in advanced or metastatic ROS1-positive NSCLC; a smart toilet seat hits the market to measure your vitals; and the FDA accepts an application for pretreated metastatic pancreatic cancer treatment, daraxonrasib.  

The latest on the multistate cyclospora outbreak; Lipfendra approved to reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia; subcutaneous starting dose regimen approved for Leqembi; NDA accepted for oral sleep apnea treatment; and Revtorpyk combination approved for advanced breast cancer.  

A new treatment is approved to reduce proteinuria in adults with primary immunoglobulin A nephropahty; a swimmer's ear treatment and the thyroid hormone replacement therapy Amerithroid are now available; Casgevy approval expanded include pediatrics; and a lupus treatment is granted breakthrough status.  

A single, once-weekly tablet could change HIV treatment landscape; weight loss drug orforglipron efficacy assessed at all stages of menopause; hemophilia treatment Hympavzi gains expanded indication; and the FDA adds a warning label for kidney injury to an over-the-counter weight loss aid.

New treatment approved for adults with complicated urinary tract infections; Xocova approved for COVID-19 postexposure prophylaxis; investigational diabetic macular edema eye drop fails to meet trial endpoint; Afrezza expanded for pediatric use; obefazimod looks promising for ulcerative colitis.

New triple hormone receptor agonist shows significant weight loss; hepatitis delta virus treatment gains accelerated approval; acne gel gains OTC designation; constipation treatment expanded to include younger patients; and the FDA extends review for camizestrant in advanced breast cancer.

US News and World Report releases their annual best over-the-counter products list; new guidance for drug safety evaluation during pregnancy; gMG indication broadened for efgartigimod; Beqalzi gains accelerated approval for MCL; and a novel treatment fast tracked for ALS.  

Ozempic tablets are now available; investigational ALS treatment gains FDA Fast Track status; positive results for aficamten in non-obstructive hypertrophic cardiomyopathy; motion sickness drug Nereus now available; Lantus alternative Langlara gains approval.

Gene therapy approved to restore hereditary hearing loss; investigational treatment shows hair coverage improvements in male pattern loss; Breztri approved as a maintenance treatment for asthma; gene editing candidate meets endpoints in hereditary angioedema trial; novel dual glucagon/GLP-1 receptor agonist demonstrates significant weight loss.

Two-drug, single-tablet approved to replace current antiretroviral regimen; Dupixent approved for pediatric CSU; novel treatment significantly improves survival in metastatic pancreatic cancer; oral semaglutide for adolescents; GLP-1 Fast Tracked for knee osteoarthritis.

Foundayo, an oral GLP-1, now available for weight loss; results from the ACHIEVE-4 trial; Filspari gains approval for FSGS; a new formulation of amlodipine, and the FDA signals support for broader use of testosterone replacement therapy.

High-dose Wegovy now available for additional weight reduction when clinically indicated; trial results for durvalumab combo treatment in patients with unresectable hepatocellular; generic dapagliflozin gets green light, paving the way for generic manufacturers; achondroplasia treatment Yuviwel now available.

Lifyorli combo approved for ovarian cancer; mixed results from Lyme disease vaccine trial; treatment approved for rare Hunter syndrome and Awiqli gets approval as once-weekly basal insulin for type 2 diabetes.

A federal court blocks changes to the childhood immunization schedule by the recently appointed vaccine advisory committee; higher dose Wegovy injection gets green light; Cosentyx expanded to include pediatric hidradenitis suppurativa; investigative triple hormone therapy shows significant weight reduction in diabetes.

Sotyktu's approval expanded to encompass active psoriatic arthritis; the FDA approves leucovorin for rare disorder, not autism; safety concerns prompt Tazverik withdrawal; FDA to review potential new hypertension treatment.