Posts in category: Uncategorized

FDA Accelerated Approval of Tukysa (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer.

Seagen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

TUKYSA was approved by the U.S. FDA in April 2020 in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. This is the first FDA-approved treatment in HER2-positive metastatic colorectal cancer. The FDA previously granted Breakthrough Therapy Designation and Priority Review for Tukysa in this setting.

The Prescribing Information for Tukysa includes warnings and precautions for diarrhea, hepatotoxicity and embryo-fetal toxicity, some of which may be severe or fatal. The most common adverse reactions (≥20%) in patients treated with Tukysa and trastuzumab were diarrhea, fatigue, rash, nausea, abdominal pain, infusion-related reactions, and pyrexia.

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FDA Approves Adacel for Immunization During Pregnancy to Help Protect Young Infants Against Pertussis

The U.S. Food and Drug Administration (FDA) has approved Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) during the third trimester of pregnancy to help protect against pertussis in infants younger than two months of age.

Adacel is a vaccine given to people 10 through 64 years of age to help prevent tetanus (lockjaw), diphtheria, and pertussis (whooping cough). If given during the third trimester of pregnancy, Adacel helps the pregnant woman create antibodies against the bacteria that cause whooping cough (pertussis) that are passed to her baby before birth. These antibodies help protect the baby against whooping cough during the first few months of life.

Pertussis, also known as whooping cough, is a highly contagious respiratory infection. Very young infants
are at the highest risk of pertussis complications because of their developing immune systems. The Centers for Disease Control and Prevention (CDC) recommends Tdap vaccination during every
pregnancy.

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FDA Approves Rykindo (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia and Bipolar 1 Disorder

Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications, today announced that the U.S. Food and Drug Administration (FDA) has approved Rykindo (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

The drug is administered via intramuscular injection once every two weeks and delivers the active ingredient, risperidone, via long-acting and extended-release microsphere technology.

Common adverse reactions in patients with schizophrenia include headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, weight increase, pain in extremity, and dry mouth.

Common adverse reactions in patients with bipolar disorder include weight gain, tremor and parkinsonism.

Schizophrenia and bipolar disorder are both severe mental disorders.

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FDA Approves use of Rybelsus (semaglutide) as a First-Line Option for Adults with Type 2 Diabetes

The FDA has approved a label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg, allowing use as a first-line treatment option for adults with type 2 diabetes who have not previously taken a diabetes treatment. This update removes a previous limitation of use that stated the medication should not be used as the initial therapy for treating patients with type 2 diabetes. Initially approved by the FDA in 2019, Rybelsus is the first and only GLP-1 analog in pill form and is indicated, along with diet and exercise, to improve glycemic control for adults with type 2 diabetes.

Rybelsus works differently than other diabetes pills to lower blood sugar in three ways: by increasing the release of insulin from the pancreas when blood sugar is high, decreasing the release of sugar from the
liver, and slowing the process of food leaving the stomach after eating. Rybelsus comprises a unique coformulation of semaglutide and an absorption enhancer called SNAC (sodium N-(8-[2-hydroxybenzoyl] amino) caprylate), which facilitates absorption of semaglutide in the stomach, making it possible to provide semaglutide as a pill.

The most common side effects of Rybelsus may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation.

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FDA Approves Airsupra (albuterol/budesonide) Metered-Dose Inhaler to Reduce the Risk of Asthma Exacerbations

Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of
exacerbations in people with asthma aged 18 years and older.

The approval by the Food and Drug Administration (FDA) was based on results from the MANDALA and DENALI Phase III trials. In MANDALA, Airsupra significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms. In DENALI, Airsupra significantly improved lung function compared to the individual components albuterol and budesonide in patients with mild to moderate asthma.

Airsupra, a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an antiinflammatory inhaled corticosteroid (ICS) is being developed by AstraZeneca and Avillion.

Possible side effects can include serious allergic reactions, heart problems, worsening of trouble breathing and possible death from too much use of Airsupra.

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The U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease.

Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an important advancement in the ongoing fight to effectively treat Alzheimer’s disease.Treatment was initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology. Patients receiving the treatment had a significant dose- and time-dependent reduction of amyloid beta plaque, with patients receiving the approved dose of lecanemab, 10 milligram/kilogram every two weeks, having a statistically significant reduction in brain amyloid plaque from baseline to Week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque.

Evaluation of Leqembi’s efficacy in this double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer’s disease supported the accelerated approval of Leqembi, which is based on the observed reduction of amyloid beta plaque, a marker of Alzheimer’s disease.

The most common side effects of Leqembi were infusion-related reactions, headache and ARIA.

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NexoBrid (anacaulase-bcdb) approved for the Treatment of Severe Thermal Burns in Adults

MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

NexoBrid (anacaulase-bcdb) is a botanical drug product containing proteolytic enzymes indicated for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns. NexoBrid (anacaulase-bcdb) is indicated for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns and can be applied in up to two applications of four hours each. A first application of NexoBrid may be applied to an area of up to 15% of the body surface area. A second application may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA.

The safety and effectiveness of NexoBrid have not been established for treatment of:

• Chemical or electrical burns
• Burns on the face, perineum, or genitalia
• Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive
vascular disease
• Circumferential burns
• Burns in patients with significant cardiopulmonary disease, including inhalation injury

NexoBrid is not recommended for wounds contaminated with radioactive and other hazardous
substances to avoid unforeseeable reactions with the product and an increased risk of spreading the
noxious substance.

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Briumvi (ublituximab-xiiy) is approved for the treatment of relapsing forms of multiple sclerosis

TG Therapeutics, Inc. has announced the U.S. Food and Drug Administration (FDA) has approved Briumvi™ (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Briumvi is the first and only anti-CD20 monoclonal antibody approved for patients with RMS that can be administered in a one-hour infusion following the starting dose. The administration schedule of Briumvi consists of a day one infusion of 150 mg administered over four hours, a day 15 infusion of 450 mg
administered in one hour, followed by 450 mg infusions every 24 weeks administered over one hour.

Briumvi is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for
the management of autoimmune disorders such as RMS. Briumvi is uniquely designed to lack certain sugar molecules normally expressed on the antibody. The removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

Briumvi is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Briumvi is contraindicated in patients with:

• Active HBV infection
• A history of life-threatening infusion reaction to Briumvi

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Olpruva receives FDA approval for patients with some urea cycle disorders (UCD’s)

Acer Therapeutics Inc. and its collaboration partner, RELIEF THERAPEUTICS Holding SA, have announced that the U.S. Food and Drug Administration (FDA) has approved Olpruva™ (sodium phenylbutyrate) for oral suspension in the U.S. for the treatment of certain patients living with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS).

Olpruva is used along with certain therapies, including changes in diet, for the long-term management of
adults and children weighing 44 pounds (20 kg) or more. It is not used to treat a rapid increase of ammonia in the blood (acute hyperammonemia), which can be life-threatening and requires emergency medical treatment.

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FDA approves Wegovy as anti-obesity medication for teens with once-weekly dosing.

Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Wegovy (semaglutide) injection 2.4 mg, making it the first-and-only prescription anti-obesity medicine for teens with once-weekly dosing.

Wegovy is now also indicated for use in adolescents (≥ 12 years old) with an initial BMI at or above the
95th percentile for age and sex (based on CDC growth charts) along with a reduced calorie meal plan and increased physical activity to lose weight and keep it off.

Adolescents treated with Wegovy had greater incidences of gallbladder problems including gallstones, low blood pressure, rash, and itching compared to adults treated with Wegovy.

Do not use Wegovy if:

• You or any of your family have ever had medullary thyroid carcinoma.
• You have an endocrine system condition called Multiple Endocrine Neoplasia syndrome
  type 2 (MEN 2).
• You have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy.

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