Posts in category: Uncategorized

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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Sunlenca approved by FDA for use with other antiretrovirals for the treatment of HIV-1 infections

Gilead Sciences, Inc. has announced that Sunlenca® (lenacapavir), in combination with other antiretroviral(s) (ARV), has been granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant (MDR) HIV-1 infection.

Sunlenca belongs to a new class of drugs called capsid inhibitors and is designed to inhibit HIV-1 at
multiple stages of its lifecycle and may work against HIV strains that are resistant to other HIV drugs.
Sunlenca offers a new, twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen.

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The FDA approved a new indication for Actemra (tocilizumab) injection (PDF, 2.6 MB) for the treatment of hospitalized adult patients with COVID-19 who are receiving systemic
corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

FDA first issued an EUA for Actemra in hospitalized adult and pediatric patients (2 years of age and older) for the same use on June 24, 2021.

Actemra remains authorized for emergency use for the same indication for hospitalized pediatric patients ages 2 to less than 18 years who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. FDA has revised the Letter of Authorization (PDF, 249 KB) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Actemra and the recommended dosage for the approved population are included in the prescribing information (PDF, 2.6 MB).

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FDA Approves Tymlos as a Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture

Radius Health, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Tymlos (abaloparatide), a parathyroid hormone related peptide [PTHrP(1-34)] analog, as a treatment to increase bone density in men with osteoporosis at high risk of fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture), or in patients who have failed or are intolerant to other available osteoporosis therapy.

Tymlos is a man-made form of parathyroid hormone that exists naturally in the body.

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FDA Approves Indication for Pemfexy in Combination with Pembrolizumab and Platinum Chemotherapy

Eagle Pharmaceuticals, Inc announced today that the U.S. Food and Drug
Administration has approved an additional indication for Pemfexy® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations. Eagle’s approved Pemfexy (pemetrexed injection) is a ready-to-dilute (“RTD”) novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug (“LD”), ALIMTA®.

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FDA Approves Vraylar (cariprazine) as an Adjunctive Treatment for Major
Depressive Disorder

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved Vraylar® (cariprazine) as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant.

The most common side effects include difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting,
indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness.

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Adstiladrin (nadofaragene firadenovec-vncg) suspension approved for intravesical use

Ferring Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approved Adstiladrin® (nadofaragene firadenovec-vncg), a novel adenovirus vector-based gene therapy, for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Bladder cancer is the sixth most common cancer in the U.S., with NMIBC representing approximately 75% of all new bladder cancer cases. BCG remains the first-line standard of care for people living with high-grade NMIBC. However, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease.

Adstiladrin, an intravesical therapy administered every three months, targets the patient’s own bladder wall cells to enhance the body’s natural defenses to fight cancer. The FDA approval was based on results of the Phase 3 clinical trial, which met its primary endpoint with more than half (51%, n=50 of 98; 95% CI 41 to 61) of patients with carcinoma in situ with or without concomitant high-grade Ta or T1 disease (CIS ± Ta/T1) achieving a complete response (CR) by three months. Of the patients who achieved an initial CR, 46% (n=23 of 50) continued to remain free of high-grade recurrence at 12 months.

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ADMA Biologics Announces FDA Approval for Room Temperature Storage of Asceniv & Bivigam

ADMA Biologics, Inc., an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental
Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to now include room temperature (25°C) storage conditions for up to 4 weeks during the first 24 months of the 36-month approved shelf
life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.

ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral
immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age).

BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to, the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency.

The newly approved room temperature storage labeling for ASCENIV and BIVIGAM is immediately effective, and product is commercially available to U.S. healthcare providers and patients.

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