Posts in category: Uncategorized

FDA Approves Selarsdi, a Biosimilar to Stelara

The FDA has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.

• Introduced through a strategic partnership between Teva Pharmaceutical Industries Ltd. and Alvotech, for the exclusive commercialization of five of Alvotech’s biosimilar product candidates, Teva will be responsible for the exclusive commercialization of Selarsdi in the United States.
• Sales of Stelara in the U.S. were nearly $7 billion in 2023. The availability of a Stelara biosimilar will create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients.
• In the U.S., plaque psoriasis is the most common form of psoriasis while psoriatic arthritis accounts for approximately six percent of all cases of juvenile arthritis.

Source: Teva Pharmaceutical Industries Ltd.

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FDA Approves Anktiva Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

ImmunityBio, Inc. has announced that the FDA has approved Anktiva plus Bacillus CalmetteGuérin (BCG) for the treatment of patients with BCG unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

• Anktiva is a first-in-class IL-15 agonist immunotherapy for NMIBC and received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR).
• Bladder cancer is the 10th most commonly diagnosed cancer globally, and in the U.S., the American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024.
• With the approval of Anktiva in combination with BCG, NMIBC, patients who would otherwise face highly invasive surgery with life long consequences have an important new therapeutic option with a long-term durable complete response.

Source: ImmunityBio, Inc.

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FDA Approves Zevtera for Bacteremia, Skin and Skin Structure Infections, and Pneumonia

The FDA has approved Zevtera® injection (ceftobiprole medocaril sodium) for the treatment of adult patients with Staphylococcus aureus bloodstream infections, including those with:

o Right-sided infective endocarditis
o Adult patients with acute bacterial skin and skin structure infections (ABSSSI)
o Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).

• Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria.
• Zevtera is contraindicated in patients with a known history of severe hypersensitivity to Zevtera, or to other members of the cephalosporin class.

Source: Basilea Pharmaceutica Ltd

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FDA Approves Xromi Oral Solution for Use in Pediatric Patients with Sickle Cell Anemia

Xromi has been approved by the FDA as an oral solution formulation of hydroxyurea indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age to less than 2 years with sickle cell anemia with recurrent moderate to severe painful crises.

• Sickle cell anemia is caused by an abnormal version of hemoglobin called hemoglobin S, which leads to sickle-shaped red blood cells that can form painful clumps inside the blood vessels. These painful episodes are called sickle cell crises and are one of the most common and distressing symptoms of sickle cell disease.
• Hydroxyurea has been shown to reduce the frequency of painful episodes associated with sickle cell disease. It is thought to work by increasing levels of hemoglobin F (also called fetal hemoglobin because it is present in newborn babies) to make the red blood cells bigger, rounder, more flexible, and less likely to turn into a sickle shape.
• Xromi, manufactured by Nova Laboratories, Ltd., is supplied as a strawberry flavored oral solution containing 100 mg/mL hydroxyurea. The Xromi package contains two oral dosing syringes.

Source: FDA

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FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia

Laboratorios Farmacéuticos ROVI, S.A. has announced that the U.S. Food and Drug Administration (FDA) has authorized the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults.

Risperidone ISM® is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults, which, as of the first injection, provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone.

Schizophrenia is a chronic, serious, and disabling mental disorder that affects around 1% of the world population. Schizophrenia patients are characterized by a mixture of symptoms, both positive (delusional ideas, hallucinations, disorganized language, and behavior) and negative (affective flattening, speech poverty, apathy) in nature. It is estimated that between 3% and 5% of total global healthcare expenditure is spent on schizophrenia.

Read more at Drugs.com…

FDA Approves Vafseo for the Treatment of Anemia due to Chronic Kidney Disease
in Adult Patients on Dialysis

AkebiaTherapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo is now approved in 37 countries.

Approximately 500,000 adult patients in the U.S. on dialysis suffer from anemia due to CKD, which may be associated with many adverse clinical outcomes. The burden of managing uncontrolled anemia in CKD patients can be substantial, both in terms of healthcare costs and the impact on patients, healthcare providers and caregivers.

Read more at Drugs.com…

FDA Approves Winrevair a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension

Merck announced that the U.S. Food and Drug Administration (FDA) has approved sotatercept-csrk (U.S. Brand Name: Winrevair™, for injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events. Winrevair was previously granted Breakthrough Therapy Designation by the FDA. Winrevair is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH.

The approval is based on the Phase 3 STELLAR trial, which compared Winrevair (n=163) to placebo (n=160), both in combination with background standard of care therapies in adult patients with PAH (WHO Group 1 FC II or III).

Healthcare providers should monitor hemoglobin and platelets before each dose of Winrevair for the first five doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required. Winrevair may increase hemoglobin and may lead to erythrocytosis, which if severe may increase the risk of thromboembolic events or hyperviscosity syndrome. Winrevair also may decrease platelet count and lead to severe thrombocytopenia, which may increase the risk of bleeding; thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Treatment should not be initiated if platelet count is <50,000/mm.

Winrevair is given once every three weeks by subcutaneous injection and may be administered by appropriate patients or caregivers with guidance, training, and follow-up from a healthcare provider. Healthcare providers and patients/caregivers should refer to the Instructions for Use for information on the proper preparation and administration of Winrevair. Merck estimates that Winrevair will be available for dispensing by select specialty pharmacies in the U.S. by the end of April 2024.

Read more at Drugs.com

FDA Approves Opsynvi (macitentan and tadalafil) for Adults with Pulmonary Arterial Hypertension

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) IIIII. Opsynvi® may be used in patients with PAH who are treatment-naïve or who are already on an ERA, PDE5 inhibitor or both. Opsynvi® may be used in patients who are currently treated concomitantly with stable doses of macitentan 10mg and tadalafil 40mg (20mg x 2) as separate tablets.

With the approval, Johnson & Johnson now offers a PAH portfolio addressing all three foundational and guideline-recommended pathways – nitric oxide, endothelin, and prostacyclin. PAH is a rare, progressive, and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to right heart failure. An estimated 500 to 1,000 new cases of PAH are diagnosed each year in the U.S., classifying the disease as a rare condition.

The 2022 European Society of Cardiology (ESC)/European Respiratory Society (ERS) clinical guidelines recommend initial combination therapy of an ERA and a PDE5 inhibitor for patients with idiopathic PAH, heritable drug-associated PAH, or PAH-associated with connective tissue disease without cardiopulmonary comorbidities at low or intermediate risk.

Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability.

Read more at Drugs.com…

DA Approves Duvyzat for Duchenne Muscular Dystrophy

Italfarmaco S.p.A. announced that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood. DMD is a severe neuromuscular genetic disease characterized by progressive muscle weakness and degeneration and is the most common type of muscular dystrophy globally. DMD is caused by mutations in the dystrophin gene that result in the absence of a functional dystrophin protein. Duvyzat, an oral suspension, received priority review, orphan drug, and rare pediatric disease designations from the FDA. A Marketing Authorization Application (MAA) for givinostat as a potential treatment for DMD has been submitted to the European Medicine Agency (EMA) and is currently under review.

Read more at Drugs.com…

FDA Approves Tryvio for the Combination Treatment of Resistant Hypertension

Idorsia Pharmaceuticals U.S. Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of Tryvio is 12.5mg orally once daily, with or without food.

Tryvio (aprocitentan) is an endothelin receptor antagonist that inhibits the binding of endothelin (ET)-1 to ETA and ETB receptors. The effects of ET-1 bear many similarities with the pathophysiology of hypertension, and ET-1 is a major driver of aldosterone production. Until the approval of Tryvio, no systemic antihypertensive medications targeted the ET pathway, as approved antihypertensive therapies focus on the regulation of salt and water (diuretics), antagonism of the renin–angiotensin–aldosterone (RAAS) system, reduction of influx of extracellular calcium into the cell (calcium channel blockers), sympatholytic activity (beta blockers, central alpha-agonist agents), or non-selective vasodilatory effects.

Tryvio is available only through a restricted program under a REMS called the Tryvio REMS because of the risk of embryo-fetal toxicity. Prescribers must be certified with the Tryvio REMS by enrolling and completing training. Pharmacies that dispense Tryvio must be certified with the Tryvio REMS.

Read more at Drugs.com…