AUCATZYL

by NewsUncategorized

FDA Approves Aucatzyl for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

Autolus Therapeutics plc has announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Aucatzyl (obecabtagene autoleucel) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

  • Aucatzyl is a CD19-directed genetically modified autologous T cell immunotherapy.
  • Aucatzyl is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy).
  • ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system, and other organs.

Source: Autolus Therapeutics plc

Read more…

Anxiety Medications and Alcohol Interactions

by NewsUncategorized

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on May 30, 2024.
Side effects like drowsiness, impaired driving, and respiratory depression (slowed breathing) can worsen when anxiety drugs are combined with alcohol. Many medicines used for anxiety should be used short-term and, in general, you should avoid or limit alcohol with these drugs. Follow the advice from your healthcare provider.

Many anxiety drugs have central nervous system depressant activity and interact with alcohol, so it is
important to understand your risks. A wide variety of medications from different classes, such as
antidepressants or benzodiazepines, are used to treat anxiety disorders.


Source: FDA; Courtesy of Drugs.com

Read More…

GENERIC DRUG APPROVALS

by NewsUncategorized

July 2024

  • Indium In-111 Pentetreotide Injection Kit 3 mCi/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

June 2024

  • Palbociclib Tablets 75mg, 100mg and 125mg
    Approved: June 5, 2024 – Synthon Pharmaceuticals, Inc.
    Treatment for: Breast Cancer
    Generic for: Ibrance Tablets
  • Avanafil Tablets 50mg, 100mg and 200mg
    Approved: June 14, 2024 – Hetero Labs Limited
    Treatment for: Erectile Dysfunction
    Generic for: Stendra
  • Phentermine Hydrochloride and Topiramate Extended-Release Capsules 3.75mg (base)/23mg,
    7.5mg (base)/46mg, 11.25mg (base)/69mg and 15mg (base)/92mg
    Approved: June 25, 2024 – Actavis Laboratories FL, Inc.
    Treatment for: Obesity
    Generic for: Qsymia

KISUNLA™

by 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…

FDA Gives Nod to RSV Vaccine for People in Their 50s

by Uncategorized

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…

MYHIBBIN™

by NewsUncategorized

FDA Approves Myhibbin Oral Suspension for Prophylaxis of Organ Rejection

Azurity Pharmaceuticals, has announced that the FDA has approved Myhibbin, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body’s immune response.

  • In 2023, there were over 46,000 transplants in the U.S. and these patients need to take medication every day to fight against rejection.
  • Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
  • It is expected that Myhibbin will become commercially available in pharmacies nationwide in Q2 2024.

Ream more…

Daybue™

by NewsUncategorized

FDA Approves Daybue (trofinetide) for the Treatment of Rett Syndrome

Acadia Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Daybue (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Daybue is the first and only drug approved for the treatment of Rett syndrome.

Rett syndrome is a complex, rare, neurodevelopmental disorder typically caused by a genetic mutation on the MECP2 gene. It is characterized by a period of normal development until six to 18 months of age, followed by significant developmental regression with loss of acquired communication skills and purposeful hand use. Symptoms of Rett syndrome may also include development of hand stereotypies, such as hand wringing and clapping, and gait abnormalities. Rett syndrome is believed to affect 6,000 to 9,000 patients in the U.S.,with a diagnosed population of approximately 4,500 U.S. patients. Daybue is not recommended for patients with moderate or severe renal impairment.

Daybue™ is expected to be available in the U.S. by the end of April, 2023.

Read more…

Zavzpret

by Uncategorized

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…

Researchers announce highly accurate blood test for Alzheimer’s Disease

by Uncategorized

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…