Soleno Therapeutics, Inc.’s Post

EXCITING NEWS FOR THE IgA NEPHROPATHY COMMUNITY 🎉 Today marks a promising day for the rare kidney disease (RKD) community: the FDA has announced that Novartis’ drug, Fabhalta (iptacopan), has been granted accelerated approval for the treatment of IgA nephropathy in adults.   As background, the FDA’s accelerated approval program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need. Fabhalta is granted accelerated approval based on reduction of proteinuria. Further evaluations will determine if the drug slows kidney function decline in IgAN patients.   Over the next several months, Novartis will share more information about this new treatment and explain when and how those who need the drug can access it. This news represents an important step forward in our continued fight to improve outcomes and quality of life for the rare kidney disease community. While there is still work to be done, this approval gives us renewed hope and determination to keep pushing research and care forward. To learn more about this development, click the link below. 🔗 https://lnkd.in/gRZqMG2S #IgANephropathy #RareDisease #FDAApproval #MedicalBreakthrough #NephCure

"A Food and Drug Administration expert panel of advisors voted 11-0 yesterday to recommend that the agency approve the Alzheimer’s disease drug donanemab. The panel concluded that the therapeutic is effective in treating the memory-robbing condition in patients with mild cognitive impairment and early-stage dementia and that the drug’s benefits outweigh the risks." Learn more reading "Alzheimer’s Disease Drug Donanemab Gets Unanimous Backing From FDA Expert Panel" #alzheimers #Donanemab #FDA #Beta #leqembi

𝐔𝐒 𝐅𝐃𝐀 𝐚𝐩𝐩𝐫𝐨𝐯𝐞𝐬 𝐍𝐨𝐯𝐨 𝐍𝐨𝐫𝐝𝐢𝐬𝐤'𝐬 𝐖𝐞𝐠𝐨𝐯𝐲 𝐟𝐨𝐫 𝐥𝐨𝐰𝐞𝐫𝐢𝐧𝐠 𝐡𝐞𝐚𝐫𝐭 𝐫𝐢𝐬𝐤𝐬 📌 USFDA approved Novo Nordisk's weight-loss drug Wegovy for lowering the risk of stroke and heart attack in overweight or obese adults who do not have diabetes. 📌Novo's widely used diabetes drug Ozempic and weight-loss drug Wegovy, both chemically known as semaglutide, belong to a class of drugs called GLP-1 agonists. Originally developed for type 2 diabetes, they also reduce food cravings and cause the stomach to empty more slowly. 📌Novo Nordisk's published the full data in November from a large clinical trial that showed the obesity drug reduced the risk of non-fatal heart attack by 28%, non-fatal stroke by 7% and heart-related death by 15%, compared with a placebo, in patients with pre-existing heart conditions #novonordisk #usfda #stroke

NEW: A blockbuster arthritis drug from Johnson & Johnson could soon see a limit on what #Colorado health plans pay for the product after the state review board determined the treatment is “unaffordable” for patients. The five-member Colorado Prescription Drug Affordability Board voted Friday to grant this designation to Stelara, an injectable drug used to treat conditions like moderate to severe plaque psoriasis and Crohn’s disease. The vote means the board will decide in a follow-up meeting whether to pursue an upper payment limit (UPL) for the drug, which the board’s affordability review found cost an average of roughly $150,000 per Colorado patient in 2022. The board’s next meeting is scheduled for June 14. The Colorado PDAB already faces a lawsuit from Amgen Inc. over the board’s February vote to move ahead with rulemaking to establish a UPL for Enbrel, an injectable treatment for autoimmune conditions like rheumatoid arthritis and psoriasis. Enbrel cost more than $46,000 per Colorado patient in 2022, according to state data. More here for Bloomberg Law: https://lnkd.in/d3s3XQ3d #prescriptiondrugs #drugprices

#liverdisease US approves drug for MASH liver disease The US has approved the first #drug to treat an obesity-linked liver disease that affects an estimated 5% of the world's adults. Resmetirom, to be marketed as Rezdiffra, treats metabolic dysfunction-associated steatohepatitis (MASH) — formerly known as non-alcoholic #steatohepatitis (NASH). After many earlier drug failures, resmetirom is the first to reduce scar tissue known as fibrosis in the liver. But researchers caution that evidence for long-term benefits is still needed. “Only time will tell,” says gastroenterologist Maya Balakrishnan. “In the end, what matters is: does this drug improve survival?” Nature | 4 min read A ‘hurrah moment’: go deeper into the development and approval of resmetirom in Nature Reviews Drug Discovery (10 min read)

Rare Diseases: Hot Trend in Drug Development, But with Caveats The Orphan Drug Act has incentivized research, leading to a boom in rare disease treatments (50% of new FDA approvals!). This means better lives for many, but also hefty price tags (avg. $32,000/year). With over 1,100 approved indications since 1983, this legislation incentivizes research for underserved patient populations. However, debates arise over the Act's efficacy and pricing. S. Sean Tu, a law professor at West Virginia University, shares his doubts on the matter 👇 #healthcare #raredisease #drugdevelopment https://lnkd.in/ex_GUaBe

Reuters notes Britain considers offering Eli Lilly and Company weight-loss drug on better terms than Wegovy; by not placing a two-year time limit on the medicine's use as it had for rival Novo Nordisk's Wegovy. For patients with a BMI of at least 35 and at least one weight-related co-morbidity, such as type 2 diabetes or heart disease, it was not appropriate to include a long-term stopping rule for tirzepatide, although it recommended considering stopping treatment if patients lose less than 5% of their initial weight after 6 months – which would be 10-15% of the population, based upon published clinical trial data. https://lnkd.in/ea_JuA4x

You may have heard about #Leqembi, the latest FDA-approved breakthrough in #Alzheimers treatment. Anyone with early-stage #Alzheimers can get a prescription—but even with #Medicare Part B coverage, not everyone can afford it. Here's what you and your community need to know about the cost, access, and effectiveness of this drug.👇 #AlzheimersAndBrainAwarenessMonth https://lnkd.in/ei7uJwXP

Big Pharma doing the right thing! "People with Down syndrome have a 90% risk of developing Alzheimer’s disease, and on average they receive their diagnosis at age 54, decades before the general population. Alzheimer’s disease currently leads to 70-80% of deaths in adults with Down syndrome. To date, no one with Down syndrome has been included in a clinical trial of donanemab or in trials of the other two anti-amyloid drugs: Leqembi (approved by the FDA in 2023) and Aduhelm (approved by the FDA in 2022)." #downsyndrome #downsyndromeawareness #idea #specialeducationadvocate #specialeducation #advocate #advocacy https://lnkd.in/gJWy_3cY

FDA Approves Seladelpar for Primary Biliary Cholangitis The FDA has granted accelerated approval to seladelpar (Livdelzi) in combination with ursodeoxycholic acid for adults with primary biliary cholangitis. The drug, a peroxisome proliferator−activated receptor delta agonist, is approved as a monotherapy for patients who have had an inadequate response to or cannot tolerate UDCA. It is not recommended in patients with decompensated cirrhosis. The accelerated approval follows positive findings from the phase 3, double-blind, placebo-controlled RESPONSE trial (N Engl J Med 2024;390[9]:783-794). In the study, researchers randomized (2:1) patients who had an inadequate response to or did not tolerate UDCA to 10 mg of oral seladelpar or placebo. Source: https://lnkd.in/diFyqBu4 #liverdisease #hepatology #liverhealth #liverproblems #liverfailure #cirrhosis #hepatitis #fattyliver #livercancer #livertransplant #liverawareness #liversupport #livercare #liverstrong #liverhealthtips #liverwellness #livernutrition #liversupportgroup