Hung Trinh’s Post

Eli Lilly and Company's Phase III trial, SURMOUNT-1, showed positive results for their blockbuster drug, Zepbound (tirzepatide), to prevent Type 2 diabetes progression in overweight patients. The trial enrolled 1,032 pre-diabetic participants and collected 3-year data on the drug's effect on the patients. After 3 years of treatment, pre-diabetic patients had a 94% reduction in the risk of developing Type 2 diabetes when compared to placebo patients. Additionally, Zepbound proved to induce significant weight loss in the participants after the 3 years. The cohort taking 5 mg of the drug had an average weight loss reduction of 15.4%, followed by the cohort taking 10 mg showing an average of 19.9%, and the cohort taking 15 mg with an average of 22.9%. Results indicate the higher the drug dosage, the higher the patient's weight loss. Learn more at the link below! https://hubs.li/Q02M5RM_0

𝐒𝐚𝐧𝐨𝐟𝐢 𝐠𝐞𝐭𝐬 𝐂𝐃𝐒𝐂𝐎 𝐏𝐚𝐧𝐞𝐥 𝐧𝐨𝐝 𝐭𝐨 𝐬𝐭𝐮𝐝𝐲 𝐀𝐧𝐭𝐢𝐝𝐢𝐚𝐛𝐞𝐭𝐢𝐜 𝐃𝐫𝐮𝐠 𝐈𝐧𝐬𝐮𝐥𝐢𝐧 𝐆𝐥𝐚𝐫𝐠𝐢𝐧𝐞 𝐚𝐧𝐝 𝐋𝐢𝐱𝐢𝐬𝐞𝐧𝐚𝐭𝐢𝐝𝐞 𝐈𝐧𝐣𝐞𝐜𝐭𝐢𝐨𝐧 📌Drug major Sanofi has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial in order to evaluate the safety and efficacy of a fixed ratio combination of Glargine 100 U/mL and Lixisenatide 33/50 mcg/mL in adults with type 2 diabetes who are suboptimally controlled on oral antihyperglycemic drugs and/or basal Insulin/GLP-1 RA (receptor agonist). 📌Insulin glargine is a synthetic version of human insulin that is FDA-approved to treat adults and children with type 1 diabetes and adults with type 2 diabetes to improve and maintain glycemic control. Insulin glargine is a long-acting insulin injected once daily and provides a basal insulin level throughout the day. 📌Lixisenatide injection is used to treat type 2 diabetes mellitus. Lixisenatide is used together with diet and exercise to help control your blood sugar. This medicine is a glucagon-like peptide-1 (GLP-1) receptor agonist. This medicine is available only with your doctor's prescription. 📌After detailed deliberation, the committee recommended the grant of permission to conduct the Phase IV study with the following changes in protocol ◾Patients on premixed and basal-bolus therapy should be excluded from the study ◾Wash-out period of 5 half-lives to be given to patients who are on DPP- 4 inhibitors. #sanofi #cdsco #Antidiabetic

Hello connections..! New update alert🚨‼️ U.S. FDA approves Travere Therapeutics kidney disorder drug: The drug, with the brand name Filspari, comes with a boxed warning for inflammation in liver and birth defects. Patients will need to be tested for liver toxicity before starting the drug. During the treatment, patients would be profiled for toxicity data on a monthly frequency for the first 12 months, and then once in every three months. New Delhi: Travere Therapeutics said on Friday the U.S. health regulator has granted accelerated approval to its drug to treat a type of chronic kidney disease, IgAN, in adults with a high risk of advancing to kidney failure.Shares of the drugmaker were up 2.8% at $18.32 after market. The drug, with the brand name Filspari, comes with a boxed warning for inflammation in liver and birth defects. Patients will need to be tested for liver toxicity before starting the drug. During the treatment, patients would be profiled for toxicity data on a monthly frequency for the first 12 months, and then once in every three months. The approval pits Filspari against Calliditas Therapeutics' Tarpeyo, which was greenlit by the U.S. Food and Drug Administration in December 2021. Filspari will be priced at $9,900 per month, making it cheaper than Tarpeyo's cost of $14,160 per month or $170,000 a year. At least three analysts expected the list price of Travere's drug to be between $70,000 and $100,000 a year. Jefferies analyst Maury Raycroft estimates that for the year, Travere could make about $35 million in 2023 from sales of the kidney drug. It is expected to have peak sales of $745 million in the United States. Travere expects to launch the drug by end of the month through its specialty distributors and specialty pharmacies in the United States. IgA nephropathy (IgAN), also called Berger's disease, occurs when immunoglobulin A antibodies, proteins made by the immune system to protect the body, build up in the kidneys, damaging tissues and leaking blood and protein into urine. The tissue damage affects the filtering ability of the kidneys, and eventually progresses to end-stage kidney failure. Analysts estimate that about 150,000 patients suffer from this condition in the U.S.

Baricitinib Outperforms TNF-Inhibitors in Treating Rheumatoid Arthritis Post csDMARDs Failure The PERFECTRA study compared the effectiveness of baricitinib and TNF inhibitors in treating rheumatoid arthritis patients who do not respond to conventional drugs. The study found that baricitinib was not only non-inferior but also superior in achieving clinical responses and improving patient-reported outcomes. Baricitinib patients had higher response rates and lower disease activity scores compared to TNFi patients. The study suggests that baricitinib could be a more effective first-line treatment for these patients. For more details please click the link! https://lnkd.in/dHgpguQa #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

✨Landmark Moment: First-Ever Approval for NASH Treatment Paradigm✨ FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard. The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended, as the FDA has approved the first drug for the fatty liver disease. After a long and winding drug development path for the common disease, Madrigal Pharmaceuticals’ resmetirom, to be sold under the brand name Rezdiffra, has become the first MASH therapy to clear the FDA finish line. Thursday, the FDA approved the tablet drug for the treatment of MASH, also known as nonalcoholic steatohepatitis (NASH), with moderate or severe liver scarring, or fibrosis, consistent with stage F2 and F3 disease, according to a product label (PDF) posted on the FDA’s website. The drug is going to benefit millions of affected population. Madrigal is pricing Rezdiffra at the wholesale acquisition cost of $47,400 before any discounts. Previously, the influential cost watchdogs at the Institute for Clinical and Economic Review figured the drug would be cost-effective under common thresholds if its net price falls between $39,600 and $50,100 per year. #NASH #MetabolicHealth #LiverHealth #HealthcareInnovation #FDAApproval #MadrigalPharmaceuticals #Rezdiffra #MedicalBreakthrough #HealthcareCosts #PublicHealth https://lnkd.in/g6TCY_y9

2024 Drug Pipeline- Not just an FYI for employers! - 12 new drugs in this report, six are expected to have a high impact on costs, four are for weight loss. - Drugs specific to conditions that impact women's health (e.g. endometriosis, post partum depression, menopause) hitting the market and in trials. - Five Cancer Vaccines in trials. - Four brand have generic alternatives coming out in 2024/35 and Three new biosimilars coming in 2024

After the FDA approved INGREZZA last year to treat chorea associated with Huntington’s disease, I wanted to better understand the development of this drug and the unique qualities claimed by its creator. I interviewed company officials at San Diego’s Neurocrine Biosciences, Inc., which fashioned valbenazine – the chemical name for INGREZZA. I had previously noted INGREZZA’S advantages over the two other FDA-approved chorea remedies, Xenazine and Austedo. INGREZZA is easier to take, requiring just one daily dose. Xenaxine and Austedo have long required multiple daily doses, although in May the FDA approved once-daily extended-release tablets for Austedo. In contrast with the other drugs, INGREZZA is a capsule – not a tablet – and is taken once daily even without an extended-release formulation. These characteristics potentially provide physicians and patients greater flexibility in dosing, because INGREZZA can be crushed and is available in three effective doses. As a result, Neurocrine’s drug, while indicated for oral administration, can also be crushed and mixed with food or provided through a feeding tube – often necessities for late-stage HD patients. In 2015 I reported on the key differences between Xenazine and its derivative Austedo, also developed in San Diego. Now I wanted to explore in detail INGREZZA’s uniqueness and its benefits for HD-affected individuals. How does it contrast with Xenazine and Austedo? Read more in my latest blog article, including our discussion of Neurocrine’s interest in developing disease-modifying treatments and cures. https://lnkd.in/gr8NaVJd

The medicines that mimic the GLP-1 hormone then became blockbusters. With close to half of the world’s population expected to be obese or overweight by 2030, according to the World Obesity Federation, demand for these drugs is surging—Bloomberg, a data provider, estimates that these medications will hit $80bn in yearly sales by then. The market is projected to grow by 26% per year in the next five years, compared with 16% per year for oncology drugs and 4% per year for immunology medicines, the two other biggest areas. So far only three GLP-1 drugs have been approved to treat obese or overweight individuals: liraglutide and semaglutide, developed by Novo; and tirzepatide, made by Lilly. Building on this momentum, pharmaceutical companies are racing to develop and bring to market new GLP-1 drugs to capture a share of this burgeoning sector. The future of GLP-1 drugs looks promising, with significant market growth and ongoing innovations expected in the coming years. As these treatments become more integrated into mainstream health care, they hold the potential to significantly impact the global fight against obesity and its associated health issues. Our company is at the forefront of this revolution, we offer high-quality semaglutide and tirzepatide APIs to help you rapidly expand your market share. If you are interested, please do not hesitate to contact us.

At the start of the year, there had been no new therapies for rare cholestatic liver disease primary biliary cholangitis (PBC) in the US for almost a decade. With the FDA approval of Gilead Sciences's seladelpar, there have now been two in a matter of weeks. #pharmaceuticalindustry #fda #liverdisease #fdaapproval #regulatoryapproval #rarediseases #pharmaceuticalsciences

Is FDA waiting for Lilly's insulin "efsitora" successful late-stage Phase III clinical trials this month, and so "blew up" Novo's application? So, we have a pushback for Novo Nordisk’s application to sell a once-weekly insulin treatment called icodec, mainly due to manufacturing process concerns raised. Novo has to accept that its application got rejected and fastly move on to satisfy all the requests coming from the FDA. Unfortunately this will send the Danish behemoth several months back before having its application for icodec being accepted for its potential use in patients with Type 1 and Type 2 diabetes. With icodec, Novo is aiming to be the first to hit the market with a weekly insulin product. Icodec as a strong blockbuster asset for Novo can offer an outstanding alternative drug product for patients with type 1 and type 2 diabetes, who now depend on multiple daily injections. It was back in May 24, 2024 that in a 7 to 4 vote, an advisory panel to the US Food and Drug Administration (FDA) determined that the potential benefits of icodec (Novo Nordisk) don't outweigh the increased risk for hypoglycemia in people with type 1 diabetes. Novo expects next year to solve the concerns raised by the FDA panel, setting back icodec's approval in the US market. Interestingly, Awiqli (as is icodec's commercial name) has been approved for Type 1 and Type 2 diabetes in Europe, Canada, Japan and Australia. China, also, moved forward and approved the drug for patients with Type 2 diabetes. The fight between Lilly and Novo not only in the anti-obesity market, but also in bringing to the market novel weekly insulin therapies for diabetes patients is heating up.