AstraZeneca, BMS, Novo Nordisk and Mylan Lead Drug Approval News
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from AstraZeneca, Bristol-Myers Squibb, Novo Nordisk, and Mylan.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, July 26, 2017 to Tuesday, August 1, 2017.
AstraZeneca Gets EU Nod for Breast Cancer Drug…
The European Commission (EC) has approved AstraZeneca’s Faslodex (fulvestrant) for treating oestrogen-receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.
Faslodex is a hormonal medicine for treating advanced breast cancer that slows tumor growth by binding to and degrading the oestrogen receptor, according to AstraZeneca. It is approved for treating HR+ advanced breast cancer in postmenopausal women with disease progression following anti-oestrogen medicine.
In the US, Faslodex is also approved, in combination with palbociclib, the active ingredient in Pfizer’s breast-cancer drug, Ibrance, for treating women with HR+, HER2-negative advanced or metastatic breast cancer, whose cancer has progressed after endocrine medicine.
Faslodex was first approved in 2002 and is currently being tested in combination with over 19 different medicines for treating women with advanced HR+ breast cancer.
..And Gets EU OK for Psoriasis Drug
AstraZeneca and MedImmune, its global biologics research and development arm, report that their partner, LEO Pharma, a specialist in dermatology care, has been granted full marketing authorization in all 28 European Union member countries plus Iceland, Liechtenstein, and Norway for Kyntheum (brodalumab), a new biologic medicine developed for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
In July 2016, AstraZeneca announced an agreement granting LEO Pharma exclusive rights to develop and commercialize Kyntheum in Europe. Outside of Europe, Valeant Pharmaceuticals has global commercial rights for brodalumab except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co. Ltd. Brodalumab is currently approved in the US (under the brand name Siliq) and in Japan for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
By binding to this specific receptor subunit on the cells of the skin, rather than targeting free inflammatory mediators, Kyntheum blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in plaque formation, according to AstraZeneca.
BMS Gets EU OK for Psoriatic-Arthritis Use…
The European Commission (EC) has approved Bristol-Myers Squibb’s Orencia (abatacept) alone or in combination with methotrexate for treating active psoriatic arthritis (PsA) in adult patients for whom the response to previous disease-modifying antirheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.
This approval, which allows for the expanded marketing of Orencia as a treatment for PsA in all 28 member states of the European Union, marks the second new indication for Orencia in less than a year. In September 2016, the EC approved Orencia, in combination with methotrexate, for treating highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. PsA becomes the third autoimmune condition, along with rheumatoid arthritis and juvenile idiopathic arthritis, for which Orencia is approved to treat in Europe.
Source: Bristol-Myers Squibb
…And Gains FDA OK for Pediatric Use for Immuno-Oncology Drug Yervoy
The US Food and Drug Administration (FDA) has expanded the indication for Bristol-Myers Squibb’s Yervoy (ipilimumab) injection for intravenous use to now include treating unresectable or metastatic melanoma in pediatric patients 12 years of age and older.
Yervoy is indicated for treating unresectable or metastatic melanoma in adults and pediatric patients (12 years and older) and as an adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.
Source: Bristol-Myers Squibb
Mylan Receives WHO Prequalification for Generic of Gilead’s Hepatitis C Drug Sovaldi…
Mylan has received approval from the World Health Organization Prequalification of Medicines Program (WHO PQ) of its application for sofosbuvir tablets, 400 mg, a generic version of Gilead Sciences’ hepatitis C drug, Sovaldi (sofosbuvir). Sofosbuvir, a directly acting antiretroviral, will be available in developing countries to treat hepatitis C.
Sovaldi is a top-selling drug for Gilead Sciences with a 2016 sales revenue of $4 billion.
Mylan’s sofosbuvir tablets, 400 mg, which are produced under license from Gilead Sciences, are the first generic version to be approved under the WHO PQ Program, according to Mylan. With WHO PQ approval, international donors and purchasers, such as UNITAID and UN. agencies, will able to fund and procure the product, and other buyers can be assured of the product’s quality, safety, and efficacy, according to Mylan.
…And Launches Generic Version of Hepatitis C Drug in India
Mylan Pharmaceuticals Private Limited, a subsidiary of Mylan N.V., has announced the launch of velpatasvir 100-mg/sofosbuvir 400-mg tablets under the brand name MyHep All in India. MyHep All is a fixed-dose combination tablet indicated for treating chronic hepatitis C virus (HCV) infection in adults, including all six major HCV genotypes. A velpatasvir 100-mg /sofosbuvir 400-mg combination product is currently sold by Gilead Sciences in other markets under the brand name Epclusa. In 2016, Epclusa had sales of $1.7 billion.
The MyHepAll launch follows Mylan’s successful January 2016 launch of MyHep LVIR (ledipasvir/sofosbuvir combination) in India. Mylan has the non-exclusive right to manufacture and distribute velpatasvir/sofosbuvir in approximately 100 developing countries via a license agreement from Gilead Sciences.
EC OKs Expanded Use for Novo Nordisk’s Diabetes Drug Victoza
The European Commission has approved an update to the European Union label to Novo Nordisk’s diabetes drug, Victoza (liraglutide) to expand the indication to reflect both improving blood sugar and cardiovascular events as integral parts of Type 2 diabetes treatment.
Victoza is a human glucagon-like peptide-1 (GLP-1) analog with an amino-acid sequence 97% similar to endogenous human GLP-1, according to Novo Nordisk. Victoza was approved in the European in 2009 and is commercially available in more than 95 countries. In Europe, Victoza is indicated for treating adults with insufficiently controlled Type 2 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 2 diabetes. In the US, Victoza was approved in 2010 as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes.
Source: Novo Nordisk
FDA OKs New Formulation for Otsuka’s Bipolar Injectable Drug
The US Food and Drug Administration has approved Otsuka Pharmaceutical’s And Lundbeck’s Abilify Maintena (aripiprazole) for extended-release injectable suspension for the maintenance monotherapy treatment of bipolar I disorder in adults.
Abilify Maintena is a once-monthly injectable formulation for intramuscular use created by Otsuka and co-developed and co-commercialized with Lundbeck.
Abiliy Maintena was approved in the US in 2013 for the treatment of adults with schizophrenia. It is a sterile lyophilized powder that when reconstituted with sterile water for injection, forms a suspension that can be administered by injection once a month (the initial injection is accompanied by an overlapping 14-day dosing of oral antipsychotic treatment).
Source: Otsuka Pharmaceutical