AstraZeneca, Roche, and GSK Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from AstraZeneca, Roche, GlaxoSmithKline, Pfizer, and Ultragenyx.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, November 15, 2017 to Tuesday, November 28, 2017.

FDA Approves AstraZeneca’s Asthma Drug Fasenra
The US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) from AstraZeneca and its global biologics research and development arm, MedImmune, for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

Fasenra binds directly to the IL-5α receptor on an eosinophil and attracts natural killer cells to induce apoptosis (programmed cell death), according to information from AstraZeneca. Fasenra will be available as a once every eight-week fixed-dose subcutaneous injection via a prefilled syringe.

In November 2017, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the marketing authorization of benralizumab. Benralizumab is also under regulatory review in Japan and several other countries.

Source: AstraZeneca

FDA OKs New Use for AstraZeneca’s Breast Cancer Drug Faslodex
The US Food and Drug Administration (FDA) has approved a new indication for AstraZeneca’s Faslodex (fulvestrant), to include use with abemaciclib, a CDK4/6 inhibitor, for treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women with disease progression after endocrine therapy.

This expanded indication for Faslodex is the second FDA approval for Faslodex in combination with a CDK4/6 inhibitor. Faslodex has been licensed in the US since 2016 for use with the CDK4/6 inhibitor, palbociclib, for treating women with HR+, HER2-negative MBC, whose cancer has progressed after endocrine therapy.

Source: AstraZeneca

FDA OKs Roche’s Hemophilia A Drug Hemlibra

The US Food and Drug Administration (FDA) has approved Roche’s Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.

Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins required to activate the natural coagulation cascade and restore the blood clotting process for hemophilia A patients, according to information from the company.  Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin once weekly. Hemlibra was created by Chugai Pharmaceutical Co., a Japanese subsidiary of Roche, and is being co-developed by Chugai, Roche, and Genentech, also part of Roche.

Source: Roche

EC Approves GSK’s Inhaler for COPD
The European Commission has granted marketing authorization for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI’) from GlaxoSmithKline (GSK) and Innoviva, a Brisbane, California-based pharmaceutical company, as a maintenance treatment in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

Trelegy Ellipta is a once-daily single inhaler triple therapy. It is a combination of an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta2-adrenergic agonist, delivered once daily in GSK’s Ellipta dry-powder inhaler. The licensed strength as delivered is FF/UMEC/VI 92/55/22 mcg.

The first European launch is expected to take place before the end of 2017.

Separately, GSK and Innoviva submitted a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with COPD.

Source: GlaxoSmithKline (European approval) and GlaxoSmithKline (sNDA to the US FDA)

FDA OKs New Use for Pfizer’s Cancer Drug Sutent
The US Food and Drug Administration has approved a new indication expanding the use of Pfizer’s Sutent (sunitinib malate) to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy (surgical removal of the cancerous kidney).

Sunitinib, a small molecule that inhibits multiple receptor tyrosine kinases, is approved for treating gastrointestinal stromal tumors and advanced renal cell carcinoma. Sunitinib was evaluated for its inhibitory activity against a variety of kinases (more than 80 kinases) and was identified as an inhibitor of: platelet-derived growth factor receptors, vascular endothelial growth factor receptors, stem cell factor receptor, Fms-like tyrosine kinase-3, colony stimulating factor receptor Type 1, and the glial cell-line derived neurotrophic factor receptor, according to information from Pfizer.

Source: Pfizer

FDA OKs New Use for Roche’s Cancer Drug Gazyva
The US Food and Drug Administration (FDA) has approved a new indication for Roche’s Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III or IV).

Gazyva is an engineered monoclonal antibody designed to attack and destroy targeted B-cells both directly and together with the body’s immune system, according to Roche. Gazyva is marketed as Gazyvaro in the European Union and Switzerland.

With this approval, Gazyva is available in the US for three different indications across two common types of blood cancer. Gazyva is currently approved in more than 80 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia, in combination with bendamustine for people with certain types of previously treated follicular lymphoma, and in combination with chemotherapy for previously untreated, follicular lymphoma.

Additional combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers, according to Roche.

Source: Roche

Amgen Launches Single-Dose Prefilled Cartridge for Autoimmune Drug Enbrel
Amgen has launched a single-dose prefilled cartridge version of its autoimmune drug, Enbrel (etanercept), called Enbrel Mini with AutoTouch, in the US for all its approved indications.

Enbrel is an injectable biologic approved for treating several chronic conditions, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and moderate-to-severe plaque psoriasis in patients four years or older.

The AutoTouch reusable autoinjector has a design that includes: a handle, a needle designed to stay hidden during the injection, a sensor to detect placement on skin, a speed switch with three injection speeds, a progress bar, and a speaker. The AutoTouch reusable autoinjector is used with Enbrel Mini single-dose prefilled cartridges (50 mg/mL) that use a new drug formulation of Enbrel that was associated with lower mean injection site pain than the current formulation.

The Enbrel Mini with AutoTouch was approved by the US Food and Drug Administration in September 2017.

Source: Amgen

FDA OKs Ultragenyx’s Rare-Disease Drug
The US Food and Drug Administration today approved Ultragenyx Pharmaceutical’s new molecular entity, Mepsevii (vestronidase alfa-vjbk), to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII, also known as Sly syndrome.

Mepsevii received orphan drug designation from the FDA, which provides incentives to assist and encourage the development of drugs for rare diseases.

The sponsor is receiving a Rare Pediatric Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for preventing and treating rare pediatric diseases.

Source: Ultragenyx Pharmaceutical and FDA

EC OKs Tesaro’s Ovarian Cancer Drug Zejula
The European Commission (EC) has granted Tesaro, a Waltham, Massachusetts-headquartered, oncology-focused pharmaceutical company, marketing authorization for Zejula (niraparib) as a monotherapy for the maintenance treatment of adult patients with ovarian cancer. The drug is slated by some analysts as a potential blockbuster drug.

Specifically, the drug is approved for treating women with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.

Zejula is a once-daily, oral poly (ADP-ribose) polymerase (PARP)1/2 inhibitor that does not require BRCA mutation or other biomarker testing.

Zejula was approved by the US Food and Drug Administration in March 2017 and is marketed by Tesaro in the US. Tesaro plans to launch Zejula in Germany and the UK this December, with launches in additional European countries to follow beginning in 2018, based on local reimbursement and availability timelines.

The drug is estimated by some analysts for blockbuster status with projected sales of nearly $1.1 billion by 2021, according to Clarivate Analytics.

Source: Tesaro

FDA Approves Janssen’s New Combo HIV Drug
The US Food and Drug Administration (FDA) has approved, Juluca, a single-pill, two-drug regimen for treating human immunodeficiency virus type 1 (HIV-1) infection in certain adults, from Janssen Therapeutics, one of the pharmaceutical companies of Johnson & Johnson.

Juluca is a once-daily, antiretroviral combination of dolutegravir, an integrase strand transfer inhibitor marketed by ViiV Healthcare as Tivicay, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor marketed by Janssen as Edurant.

Juluca is indicated as a complete regimen for treating HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

Source: Johnson & Johnson

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