All posts by : Admin

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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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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