Monthly Archives: January 2023

The Menarini Group, a leading Italian pharmaceutical and diagnostics company, has announced that the U.S. Food and Drug Administration (FDA) has approved Orserdu for the
treatment of postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Orserdu is approved under the FDA’s Priority Review and Fast Track designation.

• ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers.
• ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have
  been difficult to treat.
• Orserdu is the first endocrine innovation in more than 20 years, specifically addressing ESR1 mutations, a major unmet need.

Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, headquartered in New York will commercialize Orserdu in the U.S.

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Jaypirca (pirtobrutinib) approved for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma

Loxo@Lilly, the oncology unit of Eli Lilly and Company announced that the U.S. Food and Drug Administration approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

Jaypirca, a highly selective kinase inhibitor, utilizes a novel binding mechanism and is the first and only FDA approved non-covalent (reversible) BTK inhibitor. It was approved under the FDA’s Accelerated
Approval pathway based on response rate from the open-label, single-arm, international, Phase 1/2 study, called the BRUIN trial. Continued approval for this indication may be contingent upon verification
and description of clinical benefit in a confirmatory trial.

Jaypirca is expected to be available in the United States in the coming weeks.

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Brukinsa (zanubrutinib) Approved in the U.S. for Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration has approved zanubrutinib (Brukinsa), manufactured by the biotechnology company BeiGene, which is a next-generation BTK inhibitor, for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA reported that the most common adverse reactions seen with zanubrutinib were a decrease in neutrophil count, upper respiratory tract infection, decrease in platelet count, hemorrhage, and musculoskeletal pain.

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FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes

January 23, 2023 – TheracosBio has announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor.

Brenzavvy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Treatment can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m. It is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

Patients with eGFR less than 60 and greater than 30 mL/min/1.73 m2
are said to be in stage 3 chronic kidney disease, and for these patients, metformin is often avoided due to the risk of lactic acidosis. Brenzavvy is contraindicated in patients who are hypersensitive to bexagliflozin or any tablet ingredient and is not indicated for the treatment of type 2 diabetes in patients with end stage renal disease or who are receiving dialysis.

The FDA approval is based on results from a clinical program that evaluated its safety and efficacy in 23 clinical trials, enrolling more than 5,000 adults with type 2 diabetes mellitus.

Although Brenzavvy is not approved for weight or blood pressure reduction, modest decreases in both weight and systolic blood pressure have been observed in the clinical program. Brenzavvy is available as 20 mg oral tablets recommended to be taken once daily, in the morning with or without food.

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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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