Posts in category: Uncategorized

FDA Approves Kisunla for the Treatment of Early Symptomatic Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) has approved Kisunla™ (donanemab-azbt, 350mg/20mL injection for IV infusion) as treatment of early symptomatic Alzheimer’s disease (AD) which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.

• Once-monthly Kisunla IV infusion is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions.
• Among the overall population of Phase 3 study participants, Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study.
• The FDA’s dosing instructions state that prescribers can consider stopping the dosing of Kisunla based on removal of amyloid plaques to minimal levels as observed on amyloid PET imaging.

Read more…

July 2024

• Indium In-111 Pentetreotide Injection Kit 3mCi/mL
  Approved: July 1, 2024 – Sun Pharmaceutical Industries, Inc.
  Used for: Diagnosis and Investigation
  Generic for: Octreoscan
• Bupivacaine Liposome Injectable Suspension 133mg/10mL (13.3mg/mL) and 266mg/20mL (13.3mg/mL)
  Approved: July 1, 2024 – Jiangsu Hengrui Pharmaceuticals Co., Ltd.
  Used for: Analgesia
  Generic for: Exparel
• L-Glutamine Powder for Oral Solution 5gm/packet
  Approved: July 8, 2024 – Novitium Pharma LLC
  Used for: Sickle Cell Disease
  Generic for: Endari
• Nimodipine Oral Solution 3mg/mL
  Approved: July 9, 2024 – Annora Pharma Private Limited
  Used for: Subarachnoid Hemorrhage
  Generic for: Nymalize
• Tazarotene Topical Cream 0.05%
  Approved: July 15, 2024 – Padagis Israel Pharmaceuticals Ltd.
  Used for: Plaque Psoriasis
  Generic for: Tazorac Cream 0.05%

Medically reviewed by Drugs.com.
By Ernie Mundell HealthDay Reporter

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness.

• Drugmaker GSK’s Arexvy vaccine, as well as vaccines from Pfizer and Moderna, are already
  approved for use in adults 60 and older, since age brings higher risk from RSV disease.
• Arexvy is the first to get the nod for people ages 50 to 59 with certain health risk factors.

Read more…

Pfizer Inc. has announced the U.S. Food and Drug Administration (FDA) has approved Zavzpret (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. There are several other CGRP antagonists currently on the market — some for acute treatment of migraine, others for migraine prevention, and some can be used for both. (i.e. injectables: ajovy, aimovig, emgality, vyepti oral: qulipta, ubrelvy, and nurtec).

In its pivotal Phase 3 study, Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose. The pivotal study also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint versus placebo.

The FDA approval is based on two pivotal randomized, double-blind, placebo-controlled studies that established the efficacy, tolerability and safety profiles of Zavzpret for the acute treatment of migraine. In these studies, Zavzpret was statistically superior to placebo on the co-primary endpoints of pain freedom (defined as a reduction of moderate or severe headache pain to no headache pain) and freedom from most bothersome symptom at two hours post-dose (defined as the absence of the selfidentified most bothersome symptom).

Zavzpret is contraindicated in patients with a history of hypersensitivity to zavegepant or to any of its components. Hypersensitivity reactions, including facial swelling and urticaria, have occurred with Zavzpret in clinical studies.

Zavzpret is anticipated to be available in pharmacies in July 2023.

Read more…

A team of researchers from Rowan-Virtua School of Osteopathic Medicine (RowanVirtua SOM) and Durin Technologies, Inc., have announced the results of a newly-designed blood test that can detect the presence of Alzheimer’s disease-related pathology up to 10 years before symptoms arise with a nearly 97 percent accuracy rate. Their findings appear online ahead of press in the Journal of Alzheimer’s Disease.

The study involved 328 blood samples with the goal of determining if a test that monitors a small number of a patient’s autoantibodies can detect Alzheimer’s disease (AD)-related pathology at presymptomatic, prodromal (i.e., mild cognitive impairment), and mild-moderate stages of the disease.

The research team showed that their test, using just eight autoantibody biomarkers, could accurately identify the presence of Alzheimer’s disease pathology across the disease’s progression, including among those originally determined to have no trace of the disease.

For a number of reasons, the test has significant potential to impact effective treatments for Alzheimer’s disease. The test is minimally invasive and inexpensive, it can diagnose or predict clinical decline in asymptomatic individuals, and it can monitor a patient’s progress while under treatment, making it ideal for use in clinical trials and in frontline and community primary care settings, including those in rural and economically disadvantaged regions.

The researchers noted that the use of autoantibodies as blood-based biomarkers is particularly exciting because it enables development of a platform technology for early detection of multiple diseases.

Read more…

Eli Lilly announced the price of Rezvoglar (insulin glargine-aglr) as well as price cuts on other insulin products and a cap on out-of-pocket (OOP) costs for insulin. Lilly’s announcement was not unexpected, based on recent publicity and legislation regarding drug prices, particularly with respect to insulin.

In today’s announcement, Lilly stated that a five-pack of KwikPens will be priced at $92, which is a 78% discount to Sanofi’s Lantus (insulin glargine). This price will be effective starting on April 1, 2023.

Rezvoglar was approved as the second interchangeable biosimilar to Lantus on November 17, 2022.
Biocon’s Semglee was approved as the first interchangeable biosimilar to Lantus, and Biocon launched
both branded and unbranded versions.

Once Rezvoglar launches, patients can receive Rezvoglar or Semglee (branded or unbranded) at the pharmacy in place of branded or unbranded Lantus. Rezvoglar’s label does not specify whether it is interchangeable with Semglee, only that it is interchangeable with Lantus.

Read more…

Reata Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, has received approval from the U.S. Food and Drug Administration for Skyclarys™ (omaveloxolone) as a treatment for Friedreich’s ataxia in adults and adolescents aged 16 years and older.

Friedreich’s ataxia is an ultra-rare, inherited neurodegenerative disorder that is typically diagnosed during adolescence and affects approximately 5,000 patients in the U.S. With this approval, the FDA granted a rare pediatric disease priority review voucher. The WAC Cost for a one-month supply is noted at $370,000.

Skyclarys™, an oral once-daily medication that has received Orphan Drug designation, is also under review in Europe by the European Medicines Agency (EMA).

Treatment with Skyclarys can cause an elevation in hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]. Skyclarys can cause changes in cholesterol and increases in B-type natriuretic peptide (BNP), a marker of cardiac function.

Women are advised not to breastfeed during treatment with Skyclarys.

Anticipated commercial drug supply of Skyclarys will be available in the second quarter of 2023.

Learn more…