Posts in category: News

FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia

Sandoz, has announced that the U.S. Food and Drug Administration approved Jubbonti, (denosumab-bbdz), an interchangeable biosimilar to Prolia.

Jubbonti is approved to:

• Treat postmenopausal women with osteoporosis at high risk for fracture.

• Increase bone mass in men with osteoporosis at high risk for fracture.

• Treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture.

• Increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.

• Increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Read more…

Lantheus Announces the FDA Approval of Definity (Perflutren Lipid Microsphere) for Pediatric Patients
Lantheus Holdings, Inc, has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Definity® (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms. This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border. Currently, Definity is the most utilized, extensively studied, and a trusted diagnostic ultrasound enhancing agent in the U.S.

Clinical studies have substantiated the efficacy and safety of Definity in pediatric patients.

Read more…

Rybrevant® in Combination with Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Johnson & Johnson has announced that following a priority review, the U.S. Food and Drug Administration (FDA) has approved Rybrevant® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test. This FDA action converts the May 2021 accelerated approval of Rybrevant® to a full approval based on the confirmatory Phase 3 PAPILLON study.

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases. Alterations in EGFR are the most common actionable driver mutations in NSCLC. Clinical data show patients with EGFR exon 20 insertion mutations generally experience limited benefits with currently approved third-generation EGFR tyrosine kinase inhibitors and chemotherapy. NSCLC driven by EGFR exon 20 insertion mutations carries a worse prognosis and shorter survival rates compared with lung cancer driven by other EGFR driver mutations.

Read more…

U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy to Treat People with HIV with Suppressed Viral Loads, Pre-Existing Resistance

Gilead Sciences, Inc. has announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes.

This label update is supported by Study 4030, which evaluated the efficacy, safety, and tolerability profile of Biktarvy in a broad range of people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance. Biktarvy is now the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen that is FDA approved and U.S. Department of Health and Human Services (DHHS) guideline recommended for PWH who are virally suppressed with M184V/I resistance.

Once someone with HIV has developed resistance to a treatment, it will persist for the rest of their life. Reducing the risk of drug resistance is a key goal in HIV therapy. HIV drug resistance continues to receive clinical and public health attention because it may hinder the ability of HIV medicines to suppress and block replication of the virus over the course of an individual’s life. Resistance may lead to treatment failure in individuals, while also creating the potential for transmission of treatment-resistant HIV within communities.

Read more…

FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to Humira

Alvotech and Teva Pharmaceuticals, have announced that the U.S. Food and Drug Administration (FDA) has approved Simlandi (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. In 2023, Humira was one of the highest-grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion. Teva is Alvotech’s strategic partner for the exclusive commercialization of Simlandi in the United States.

Simlandi is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection. While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S. today, nearly 88 percent of U.S. prescriptions for adalimumab are for the highconcentration presentation.

Read more…

FDA Approves new indication for Xolair

The U.S. Food and Drug Administration (FDA) approved a new indication for Genentech/Novartis’ Xolair (omalizumab), an anti-immunoglobulin E (IgE) antibody. Xolair is now indicated for IgE-mediated food allergy in adult and pediatric patients 1 year of age and older for the reduction of allergic reactions (Type I). This includes anaphylaxis, that may occur with accidental exposure to one or more foods. Xolair is intended to be used in conjunction with food allergen avoidance.

Xolair was first approved in 2003 for moderate to severe persistent allergic asthma and has since been approved for perennial aeroallergen allergies, to treat chronic idiopathic urticaria, and as an add-on maintenance treatment for nasal polyps in adults with inadequate response to nasal corticosteroids. Xolair does not treat acute allergic food reactions and does not replace the use of epinephrine for such reactions. Patients taking Xolair for food allergies may need to continue to carry epinephrine for treating emergency allergic reactions.

Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure. Aimmune Therapeutics’ Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp) is an oral immunotherapy product approved in patients 4–17 years of age for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut, but its use is restricted to peanut allergy. There are other agents in development for food allergies, including some for multiple food allergies.

Read more…