BI, Biogen, Novartis, and Merck & Co. Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Biogen, Novartis, and Merck & Co.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, August 23, 2017 to Tuesday, August 29, 2017.

Boehringer Ingelheim Gets FDA OK for Biosimilar to AbbVie’s Humira
The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s (BI) Cyltezo (adalimumab), a biosimilar to Abbvie’s anti-inflammatory drug Humira.  Humira had 2016 revenues of $16.08 billion.

The approval included indications for the following: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, plaque psoriasis.

In granting approval for the drug, the FDA approved Cyltezo to be manufactured at BI’s biomanufacturing facility in Fremont, California. In July 2017, BI announced a $217-million investment to upgrade and expand its Fremont, California manufacturing facility. 

Cyltezo is another adalimumab biosimilar to be approved by the FDA. In September 2016, Amgen received approval from the FDA for Amjevita (adalimumab-atto) across all eligible indications of the reference product.

Source: FDA

Biogen, Samsung Bioepis Get EU OK for Biosimilar to AbbVie’s Humira
The European Commission (EC) has granted a marketing authorization to Biogen and Samsung Bioepis, an Incheon, South Korea-headquartered biopharmaceutical company, for Imraldi (adalimumab), a biosimilar referencing Abbvie’s anti-inflammatory drug Humira. Humira had 2016 sales of $16.08 billion.

Imraldi was developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics, a Seoul, Korea-based contract biologics manufacturer.

The drug is approved for treating rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.

Imraldi is another biosimilar from Biogen and Samsung Bioepis to receive marketing authorization in the European Union (EU) following the 2016 approval of Benepali (etanercept), a biosimilar referencing Amgen’s Enbrel, and Flixabi (infliximab), a biosimilar referencing Johnson & Johnson’s Remicade, respectively in January 2016 and May 2016.

The EC approval of Imraldi applies to all 28 EU member states as well as the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. Biogen will commercialize Imraldi in the EU and EEA member states.

Source: Biogen and Samsung Bioepis

Novartis Gets EU OK for Breast-Cancer Drug
The European Commission (EC) has approved Novartis’ cancer drug Kisqali (ribociclib) in combination with an aromatase inhibitor for a certain type of breast cancer. Specifically, the drug is approved for treating postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative locally advanced or metastatic breast cancer as an initial endocrine-based therapy.

Kisqali is a selective cyclin-dependent kinase inhibitor, a type of drug that helps slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6), according to Novartis.

The EU approval follows a positive opinion granted in June by the Committee for Medicinal Products for Human Use of the European Medicines Agency. The opinion included a recommendation that allows oncologists the flexibility to prescribe Kisqali with any aromatase inhibitor (i.e., letrozole, anastrozole or exemestane) they deem most appropriate for their patient.

The approval is applicable to all 28 European Union member states plus Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway with other health authorities worldwide.

In March 2017, the US Food and Drug Administration approved Kisqali, in combination with any aromatase inhibitor, as a treatment for metastatic breast cancer.

Kisqali was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals, a Cambridge, UK-based biotechnology company.

Source: Novartis

Merck KGaA Gets EU OK for MS Drug
The European Commission has granted a marketing authorization to Merck KGaA for Mavenclad (cladribine tablets) 10 mg for treating highly active relapsing multiple sclerosis (RMS). The approval is in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein, and Iceland.

Mavenclad is an oral short-course treatment to provide efficacy across key measures of disease activity in patients with highly active RMS, including disability progression, annualized relapse rate, and magnetic resonance imaging activity, according to Merck KGaA.

Mavenclad is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as September 2017. In addition, Merck KGaA says it plans additional filings for regulatory approval in other countries, including the US. Mavenclad is currently under clinical investigation and not yet approved for the treatment for any use in the US or Canada.

Source: Merck KGaA

FDA OKs New Use for Novo Nordisk’s Victoza
The US Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s diabetes drug, Victoza (liraglutide), to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke, and CV death, in adults with Type II diabetes and CV disease.

Victoza is a human glucagon-like peptide-1 analog that was approved by the FDA in January 2010 as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes. It is commercially available in 95 countries.

In August 2017, the European Commission approved an update to the European Union label to Victoza to expand the indication to reflect both improving blood sugar and cardiovascular events as integral parts of Type II diabetes treatment. In Europe, Victoza is indicated for treating adults with insufficiently controlled Type II diabetes, together with diet and exercise, as a monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other medicinal products for treating Type II diabetes.

Source: Novo Nordisk

Shire Launches Once-Daily ADHD Drug
Shire has launched Mydayis (mixed salts of amphetamine) as a prescription drug for attention deficit hyperactivity disorder (ADHD) in the US.

Mydayis is a once-daily, extended-release treatment comprised of three types of drug-releasing beads. The US Food and Drug Administration approved Mydayis as a new dosage form in June 2017 for patients 13 years and older with ADHD.

Source: Shire

FDA Approves AstraZeneca’s Monotherapy for Expanded Use in Breast Cancer
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Faslodex (fulvestrant) 500 mg as monotherapy for expanded use in breast cancer.

The new use is for women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy.

First approved in 2002, Faslodex was used as a monotherapy for treating post-menopausal women with HR+ metastic breast cancer (MBC) whose cancer had progressed following prior anti-oestrogen therapy. In 2016, the FDA approved Faslodex in combination with palbociclib for treating women with HR+, HER2- advanced or MBC, whose cancer has progressed after endocrine therapy.

In July 2017, the European Commission approved Faslodex for treating oestrogen-receptor positive, locally-advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.

Source: AstraZeneca

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