ParetoHealth’s Post

FDA Approves Madrigal Pharmaceuticals' #resmetirom: First drug to treat NASH with F2-F3 fibrosis; set to debut under the brand name #Rezdiffra🎉🚀 🔑 Key Highlights: Available as tablets in in 3 SKUs: 60 mg, 80 mg, or 100 mg Recommended dosage: 💊80 mg: for bodyweight <100 kg (🔻reduced to 60mg with concomitant use of moderate CYP2C8 inhibitors) 💊100 mg: for bodyweight ≥ 100 kg (🔻reduced to 80mg with concomitant use of moderate CYP2C8 inhibitors) 📜 Prescribing information carrying no black box warning 🚫, no contraindications, no monitoring requirements beyond SoC, and no mandate for liver biopsy diagnosis requirement marks a major #win for Madrigal 🏆 💰💵Commercial pathway for Rezdiffra: - ⏰Reduce time to fill #prescriptions from ~60 days to ~30 days within 6 months post-launch - 📈Increase commercial lives coverage to approx. 80% by YE 2024 Madrigal has set up commercial and medical leadership team with 25+ years of experience in dozens of blockbuster launches - 💸To be listed at a #WAC price of $47,400, which falls well under the ICER cost-effectiveness threshold range of $39,600 - $50,100 - 📅 Expected to be available to patients in the US by April through a limited specialty pharmacy network 👩⚕️Patient Support Programs enables: 🔹 Commercial patients could receive a $10 co-pay 🔹Uninsured/ patients without coverage may be eligible to receive Rezdiffra for free Business and Launch Expectations: 🌐Madrigal anticipates full Medicare coverage beginning in early 2025 📊 Based on the annual review process for new medications, Madrigal expects the business split to be 50-55% commercial, 35-40% Medicare, 10% Medicaid 🚀Launch gross-to-net figures may exhibit variability until the reimbursement pathway stabilizes   💡Key Insights from the Q&A Session: ➡️ Patients with mild to minimal fibrosis and elevated cardiovascular risk may find non-liver-targeted treatments such as GLP-1s more suitable. Conversely, individuals with moderate to advanced fibrosis might benefit from Rezdiffra, a liver-focused therapy that could enhance prognosis ➡️ The company's current GTM strategy does not include plans to contract Rezdiffra currently, rather, are eager to engage in payers’ discussions 🌟 This approval marks Rezdiffra as the first drug to be marketed in the US to treat NASH, setting it as a standard for potential future treatments ✅ With no near-term competitor approvals around, the FDA approval also grants Madrigal, market exclusivity and first-mover advantage providing a competitive edge to establish resmetirom as a trusted brand in the market potentially leading to long-term revenue generation ✅ Although the initial launch targets ~315,000 patients (F2, F3), the supporting trials in early and late-stage NASH, can grant Madrigal, the access to an unexplored $1.2 billion market in the US alone   #NASH #MASH #Madrigal #NASH #MASH #fdaapproval #secondaryresearch #PDUFA #competitiveintelligence #marketresearch #insights #pharma #datazymes #DZ

Boehringer Ingelheim Partners With GoodRx to Offer #Humira Biosimilar at 92% Discount - BioSpace In a bid to take advantage of Humira’s slow loss of market share, Boehringer Ingelheim is offering its biosimilar at a 92% discount exclusively to patients who buy the product on GoodRx. Boehringer Ingelheim on Thursday announced that it has launched a patient affordability initiative in partnership with prescription savings platform GoodRx to offer its Humira (adalimumab) biosimilar, Adalimumab-adbm, at a steep discount relative to the branded reference product. Both the high- and low-concentration formulations of Adalimumab-adbm—available either as a pre-filled syringe or an autoinjector—will go for $550 per two-pack on GoodRx, representing a 92% discount from Humira’s list cost. This price is only available through GoodRx. “Patients with certain chronic inflammatory diseases who do not have insurance or are underinsured may not be able to afford essential biologic medicines, including biosimilars, to treat their disease,” Chris Marsh, senior vice president of Value and Access at Boehringer Ingelheim, said in a statement. The GoodRx partnership is a “significant step in addressing access and affordability” of medications “in one of the largest therapeutic categories with a high cost burden for patients,” according to the pharma’s announcement. The exclusive GoodRx pricing took effect Thursday. First approved by the FDA in October 2017 for multiple chronic inflammatory diseases, Adalimumab-adbm is also sold under the brand name Cyltezo. It carries the FDA’s interchangeability designation, meaning it can be used in place of the reference product without needing to change a patient’s prescription. In May 2024, the FDA signed off on a high-concentration and citrate-free version of Cyltezo, which could make injections less frequent and less painful. Boehringer Ingelheim is also offering an unbranded version of Cyltezo at an 81% discount relative to Humira’s price. https://lnkd.in/e_-KmNgh

Overactive Bladder Treatment Advances as Gemeinsamer Bundesausschuss (G-BA) Begins Benefit Assessment for Vibegron The Gemeinsamer Bundesausschuss (G-BA) has initiated a benefit assessment for Vibegron, a new overactive bladder treatment developed by Pierre Fabre Laboratories. This process, starting on October 1, 2024, will evaluate whether Vibegron offers significant advantages over existing fixed-price medications. Healthcare providers and patient groups are encouraged to participate in the review, with a final decision expected by mid-March 2025. The assessment aims to determine if Vibegron can enhance treatment options for overactive bladder, potentially improving patient outcomes and setting new therapeutic standards. For more details please click the link! https://lnkd.in/dB7i-wVb #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

We are pleased to be featured in Outsourcing-Pharma today regarding our early results report of the CANPAIN clinical trial announced last week. These results have presented promising outcomes for an alternative treatment for Chronic Pain patients. The results have demonstrated a significant reduction in pain and opioid use through cannabis-based medicines. It's a step forward in enhancing patient quality of life and potentially offering cost-effective solutions to the NHS. Read the full article here: https://lnkd.in/drMkyDch . #HealthcareInnovation #CeladonPharma #Celadon #ClinicalTrial #ChronicPainManagement #MedicalAdvancements #HealthcareInnovation #Pharmaceuticals #PatientCare #UKHealthcare #ResearchEthics #NHS #MHRA #uklifesciences #lifesciences #lifescienceindustry #pharmaceuticals #gmp #cannabiscultivation #pharmaceuticalmanufacturing #pharma #medicalcannabis #investors #investor #aim #londonstockexchange #lse #investing #invest #RNS #companyannouncement #investorupdate

Exciting news coming from Merck. The FDA has just approved Merck's Winrevair, a groundbreaking drug designed to treat pulmonary arterial hypertension (PAH), offering hope to thousands suffering from this rare condition. Winrevair targets the root cause of PAH, a significant advancement compared to existing symptom-management medications. With an estimated annual sales projection of $5 billion by 2030, this approval marks a pivotal moment for Merck's growth strategy. Winrevair's unique administration method and promising trial results demonstrate its potential to significantly improve the quality of life for PAH patients, offering a more convenient and effective treatment option. Following this big leap in the pulmonology space, what other advancements do you foresee following suit? Winrevair offers the advantage of allowing patients or caregivers to administer it under the skin with proper training from a healthcare provider, unlike some existing PAH treatments that necessitate administration by medical professionals at an infusion center. “One of the things we heard very loud and very clear, from both patients and physicians, is that they wanted something that you could get at home,” says Merck Chief Medical Officer Eliav Barr. Read more about this in the article in the comment below. #merck #winrevair #PAH #fdaapproval #pulmonology #medicalinnovation #healthcare #treatmentoption #raredisease #patientcare #healthtech #medicalbreakthroughs

FDA Approves Ascendis Pharma's Yorvipath for Hypoparathyroidism The #FDA has granted approval to Ascendis Pharma for #Yorvipath (palopegteriparatide), a groundbreaking treatment for adults with the #RareEndocrineDisorderHypoparathyroidism. This approval marks a significant milestone for patients who have long faced the limitations of conventional therapies. Yorvipath, a once-daily subcutaneous injection, is designed to restore normal #ParathyroidHormone levels, providing a crucial solution for managing both short- and long-term symptoms of the condition. #AscendisPharma is currently finalizing the manufacturing process for Yorvipath, with plans to launch the product in the U.S. by the first quarter of 2025. However, if the FDA approves the #Commercialization of existing batches, Yorvipath could reach the market as early as Q4 2024. At launch, a comprehensive #PatientSupportProgram will be introduced, offering financial assistance and guidance throughout the treatment process. Patty Keating, Executive Director of the HypoPARAthyroidism Association, described the approval as "an important milestone" for the patient community, highlighting the new treatment option as a significant advancement beyond the limits of conventional therapy. This approval follows a rigorous process, during which Ascendis addressed initial manufacturing concerns raised by the FDA. With the challenges overcome, Yorvipath now offers new hope to those affected by #Hypoparathyroidism. Stay tuned for further updates as Yorvipath approaches market availability! #FDAApproval #Yorvipath #Palopegteriparatide #Hypoparathyroidism #RareDisease #EndocrineDisorder #PharmaNews #PatientCare #HealthcareInnovation #AscendisPharma #RASLifeScienceSolutions #MarketIntelligence #MarketResearch #CompetitiveIntelligence #StrategySupport #PortfolioOptimization Detailed News: https://lnkd.in/dw5itCcv Follow our page for more industry updates: https://lnkd.in/de5zNWmK

Aug 20 (Reuters) - Eli Lilly's (LLY.N) weight-loss drug, Zepbound, drastically cut the risk of developing type 2 diabetes in overweight or obese pre-diabetic adults after three years of weekly injections, the drugmaker said on Tuesday. Shares of Lilly rose 4.4% to $962.02 in early trading, adding to an over 60% rise in stock value this year. In a trial involving 1,032 adults, patients who were on weekly injections showed a 94% reduction in the risk of progression to type 2 diabetes, compared with placebo, Lilly reported in a statement. "We just don't see numbers like this in metabolic space," BMO Capital Markets analyst Evan Seigerman said. He added that Novo's drug had also showed a 73% risk reduction after three years in a separate late-stage trial. The Indianapolis, Indiana-based company said the data comes from the longest completed trial of the drug, and reinforces the long-term benefits of tirzepatide - the chemical name of its Zepbound and Mounjaro treatments. Both Eli Lilly and rival Novo Nordisk (NOVOb.CO) have been pushing to extend the use of their obesity drugs to related conditions, which would help expand the patient pool and gain wider insurance coverage. Early results from its late-stage trial, "SURMOUNT-1", were initially disclosed in 2022. The data at that time showed the drug helped cut weight significantly in obese patients, helping it to secure U.S. regulatory approval. It was unclear if the company could file for approval to prevent diabetes based on the data, Leerink analyst David Risinger said. A pre-diabetes approval, however, could be a big upside for the stock, he added. Lilly also said patients began to regain weight and showed some increase in the progression to type 2 diabetes when they stopped treatment during the trial. Detailed data would be presented later, it said. Lilly's data comes amid concerns that patients reduce the use of weight-loss drugs over time. Reuters reported in July that only one in four U.S. patients prescribed Novo's Wegovy or Ozempic for weight loss two years ago were still taking the popular medications.

This is scary! Eli Lilly recently announced that they've launched a website that will enable people to order tirzepatide, their proprietary weight loss injection (brand name Zepbound) which costs just over $1,000 a month, directly from the manufacturer. They’re also going to service patients with diabetes and migraine. Superficially, if they are going to provide these medications directly to the public at a lower cost, that’d be one thing, but the scary part (to me at least) is that this website is also going to connect patients to “independent” telehealth providers who can prescribe the medication(s) for them. Wow! It’s one thing for CVS or Walmart to have a retail clinic inside where patients can be conveniently evaluated for a myriad of simple, acute conditions and be prescribed medications that they can pick up in the store, but having a pharmaceutical company directly employ (or contract with) providers that will prescribe their own medications which can then be “filled” and sent directly to the home just seems like a step too far. These drugs should be part of a comprehensive approach to care which includes a primary care physician and a support team that will monitor and manage the patient longitudinally and collaboratively. Isn't this a pretty slippery slope? Does anyone else find this worrisome? If we’ve gone from direct-to-consumer advertising for prescription meds to provider organizations that specialize in management of specific conditions where they prescribe and manage treatments disconnected from the primary care team to the drug company directly prescribing their own meds, what’s next? Please share your thoughts. Am I over-reacting? https://lnkd.in/g4eH7Y7Y