Napo Pharmaceuticals, Inc.’s Post

𝐅𝐃𝐀 𝐀𝐩𝐩𝐫𝐨𝐯𝐞𝐝 𝐄𝐲𝐥𝐞𝐚 𝐁𝐢𝐨𝐬𝐢𝐦𝐢𝐥𝐚𝐫 𝐀𝐟𝐥𝐢𝐛𝐞𝐫𝐜𝐞𝐩𝐭-𝐦𝐫𝐛𝐛 𝐟𝐨𝐫 𝐒𝐞𝐫𝐢𝐨𝐮𝐬 𝐑𝐞𝐭𝐢𝐧𝐚𝐥 𝐃𝐢𝐬𝐞𝐚𝐬𝐞𝐬 👉 𝐅𝐨𝐫𝐦𝐲𝐜𝐨𝐧 and its licensing partner 𝐊𝐥𝐢𝐧𝐠𝐞 𝐁𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚 announced the FDA approval for 𝐀𝐡𝐳𝐚𝐧𝐭𝐢𝐯𝐞 (𝐚𝐟𝐥𝐢𝐛𝐞𝐫𝐜𝐞𝐩𝐭-𝐦𝐫𝐛𝐛), making it the third approval for a biosimilar referencing 𝐄𝐲𝐥𝐞𝐚 (𝐚𝐟𝐥𝐢𝐛𝐞𝐫𝐜𝐞𝐩𝐭) 👉 Ahzantive has received FDA approval for treating patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases, including diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion 👉 Additionally, a marketing authorization application for Ahzantive was submitted to the European Medicines Agency (EMA) at the end of 2023, A decision from the EMA is anticipated by early 2025 👉 The approval was based on a data package that included pre-clinical, clinical, analytical, and manufacturing data; Aflibercept-mrbb showed comparable safety, efficacy, pharmacokinetics, and immunogenicity compared with the reference product among a cohort of patients with nAMD 👉 𝐀𝐇𝐙𝐀𝐍𝐓𝐈𝐕𝐄 is a registered trademark of Klinge Biopharma GmbH

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

💊Check out this interesting paper by Abidi Emna et al. Sustaining Life versus Altering Life-Saving Drugs: Insights to Explain the Paradoxical Effect of Extracorporeal Membrane Oxygenation on Drugs 🔗More info: https://brnw.ch/21wNbFl #clinical #medicine #openaccess #ecmo #antimicrobialdrugs #sedativedrugs #pharmacokinetics #pharmacodynamics

New article in Drugs in Context High-dose amphotericin: yay or nay? A case series and literature review Kayla Stover, Taylor E Jordan, Jamie L Wagner, Katie E Barber Case series and literature review on the use of a high-dose lipid formulation of amphotericin B in patients primarily in intensive care units, with varying treatment histories and outcomes. #drugsincontext #fungalinfections #fungicides #pharmacology #infectiousdiseases #casestudy https://lnkd.in/dPRVNZtn

Have you heard of this new injectable pharmaceutical for canine arthritis called Librela? 🤔 You might want to put a paws on that if it's offered for your pet. 🐾 Here's why: 🏢 Manufacturer Alert: This new injectable drug, a sibling to the concerning Apoquel, is produced by Zoetis, a multi-billion dollar major pharmaceutical player. Given the shadowy side effects linked to Apoquel, it's prudent to approach this new drug's safety with skepticism. 💊 Drug Class Insight: Similar to Apoquel, this injectable is a “maB” (monoclonal antibody), artificially crafted antibodies not native to the body. While aimed at targeting a chemical in arthritic joints, the potential risks and expenses raise significant concerns. 🤔 maB Inhibition Worries: Selective targeting in drugs doesn't always go as planned. Consider the history of antibiotics and chemotherapy. Could inhibiting "canine nerve growth factor (NGF)" have broader effects, impacting the nervous system's development and function? 📑 Short-Term Safety Studies: Arthritis is a chronic ailment, yet safety studies for this drug only cover a brief period (9 months). What happens when administered long-term? The unknowns are unsettling. ❌ Lack of Human Approval: The absence of approval for human versions is a red flag. Similar drugs raised FDA concerns, causing serious bone disorders and accelerated joint destruction. Not exactly the outcomes you'd expect from a joint pain solution. 👉 Empower Yourself: If faced with the decision for your dog, be armed with knowledge. A simple "Thanks, but we'll research further before deciding" could be a wise response. Your pet's well-being deserves a cautious approach. 🌿 Reach for Nature's Medicine Instead: Our EASE blend, formulated with turmeric and frankincense, which also have anti-inflammatory properties, work synergistically together to relieve pain associated with joint health and helps aid with joint support. #healingnaturally

📌US FDA GRANTS ACCELERATED APPROVAL TO GENFIT AND IPSEN'S LIVER DISEASE DRUG ° The FDA gave fast approval to French medication producers Ipsen and Genfit's drugs for a chronic inflammatory liver condition, Iqirvo, according to the firm on Monday. ° Primary biliary cholangitis (PBS) is an inflammation of the tiny bile ducts in the liver that eventually destroys them. It predominantly affects women aged 30 to 60, impacting 75,000 in the United States. ° Iqirvo's estimated price is $11500 for a month's supply, and it is now available for prescription by healthcare providers in the US, according to Ipsen. ° Ipsen said that standard approval for Iqirvo may be reliant on confirmatory trials, as improvement in survival or prevention of liver decompensation events, such as abdominal swelling or gastrointestinal bleeding, has not been established. ° Ocaliva by Intercept Pharmaceuticals is approved for PBC patients in combined with ursodeoxycholic acid (UDCA) or as monotherapy in patients who are unable to tolerate UDCA. Iqirvo will also be utilized under similar conditions, depending on the approval. ° Iqirvo's approval was based on data from a 161-patient late-stage trial, in which it reduced the level of an enzyme called alkaline phosphatase, which can lead to liver damage. ° It works by activating particular receptors that reduce inflammation, increase transit of bile acids outside the liver, and enhance their detoxification, according to Cherstelle Huguet, executive vice president of Ipsen. ° Current treatments do not address liver inflammation or scarring, nor do they promote bile acid detoxification. Huguet added. ° In the study Iqurvo also demonstrated an improvement in itchy skin, a symptom of PBC, over placebo; other therapies, such as ocaliva, could worsen itching. ° In 2021, Ipsen acquired global licensing rights for the medication from Genfin.Genfit received 120 million euros ($129.19 million) up front and is eligible to get double-digit royalties of up to 20%. ° Gilead is also developing a drug for PBC, and the FDA is likely to decide in August ($1=0.9289 euros). #usfda #fda #genfit #ipsen #gilead #primarybiliarycholangitis #chronicinflammatoryliver

Study Highlights Cost-Effectiveness and Safety of Bevacizumab Biosimilars for Diabetic Macular Edema A study conducted in the Indian market compared the use of bevacizumab biosimilars to the original drug, Avastin, for diabetic macular edema

Exciting news! The FDA has approved biosimilars that offer new treatment options for macular degeneration and other eye diseases. Read more about this treatment below! #ArtemisFactor #Pharma #EyeHealth #FDAApproval #Biosimilars #MacularDegeneration #HealthcareInnovation #PharmaLeadership #ProjectManagement #WomenOwnedBusiness

Eohilia, an oral suspension formulation of the corticosteroid budesonide, has surprisingly won over the FDA even after the drug’s developer, Takeda, had at one point abandoned the program following an FDA rejection. The product, indicated for treating people 11 years and older with the inflammatory disease eosinophilic esophagitis (EoE) becomes the first FDA-sanctioned oral med for the condition. In 2022, Sanofi and Regeneron’s injectable Dupixent claimed the title as the first FDA-approved therapy for EoE. Eohilia’s approval comes after some twists and turns following a regulatory delay caused by additional data submissions, before being rejected by the FDA in late 2021, which requested data from an additional clinical trial. Takeda initially stopped the programme after reflecting on the additional investment required to conduct this additional trial but surprised everyone refiling shortly before October 2023. For this, Takeda’s R&D chief Andy Plump, M.D., Ph.D. explained that “Takeda worked with patient’s communities to include additional data around Eohilia’s benefits in the resubmission.” which allowed them to demonstrate “strong data and remaining unmet need in the U.S. [which] spurred significant grassroots support” Eosinophilic esophagitis is a chronic inflammatory disease that can cause painful damage to the esophagus, resulting in difficulty in swallowing. The condition affects about 1 in 2,000 people in the U.S., and Takeda has estimated Eohilia could reach $300 million to $500 million in peak sales.

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