AstraZeneca, Bayer, J&J, and Sanofi Lead Drug Approval News

A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from AstraZeneca, Bayer, J&J, and Sanofi.

Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday April 26, 2017 to Tuesday May 2, 2017.

AstraZeneca Gains FDA OK for Bladder Cancer Drug
AstraZeneca and its global biologics research and development arm, MedImmune, have received accelerated approval from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) for treating locally advanced or metastatic urothelial carcinoma (mUC). Imfinzi was approved under the FDA’s accelerated approval pathway based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Imfinzi, a human monoclonal antibody directed against programmed death-L1, is specifically indicated for treating mUC in patients who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. The drug is also under investigation in a Phase III trial as first- line treatment in urothelial carcinoma as monotherapy and in combination with tremelimumab.

Source: AstraZeneca

AstraZeneca Gains EC Approval for Lung Cancer Drug
The European Commission has granted full marketing authorization to AstraZeneca for Tagrisso (osimertinib) 40 mg and 80 mg once-daily tablets for treating non-small cell lung cancer (NSCLC). The drug is specifically indicated for treating locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC.

In March 2017, AstraZeneca received full approval from the US Food and Drug Administration for Tagrisso in the same indication. Tagrisso is currently approved in more than 45 countries including the US, European Union, Japan, and China. It is also being investigated in the adjuvant and metastatic first-line settings, including in patients with and without central nervous system metastases, in leptomeningeal metastases, and in combination with other treatments.

Source: AstraZeneca

FDA OKs Bayer’s Anti-Cancer Drug for Liver Cancer
Bayer has received US Food and Drug Administration (FDA) approval for Stivarga (regorafenib) tablets for treating hepatocellular carcinoma (HCC), or liver cancer. With this approval, Stivarga is specifically indicated in the second-line treatment of HCC in patients who have been previously treated with Nexavar (sorafenib), Bayer’s anti-cancer drug approved by the FDA in 2005.

Stivarga is an oral inhibitor of multiple kinases involved in normal cellular functioning and in pathological processes such as oncogenesis, tumor angiogenesis, metastasis, and tumor immunity. The FDA granted fast track designation and orphan drug designation to Stivarga in the HCC indication. Additional regulatory filings for Stivarga in HCC are under review in other countries, including the European Union (EU), Japan, and China. Decisions in the EU and Japan are expected later this year. In the US, Stivarga is also indicated for treating metastatic colorectal cancer and locally advanced, unresectable or metastatic gastrointestinal stromal tumor.

Regorafenib, the active ingredient in Stivarga, was developed by Bayer. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, a South San Francisco, California-based biopharmaceutical company and now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

Source: Bayer 

EC OKs BMS’ Anti-Cancer Drug for Head and Neck Cancer
Bristol-Myers Squibb has received approval from the European Commission for the use of Opdivo (nivolumab), a programmed death-1 immune checkpoint inhibitor, as monotherapy for treating squamous cell cancer of the head and neck (SCCHN). Opdivo, a blockbuster drug for BMS, had 2016 sales of $3.77 billion.

Opdivo is currently approved in more than 60 countries, including the US, the European Union, and Japan. In the US, Opdivo is indicated for treating unresectable or metastatic melanoma as a single agent and in combination with Yervoy (ipilimumab), metastatic non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, recurrent or metastatic SCCHN, and advanced or metastatic urothelial carcinoma.

Source: Bristol-Myers Squibb 

EC Extends Approval of J&J’s Myeloma Drug
Janssen-Cilag International, a Johnson & Johnson company, has been granted approval by the European Commission (EC) to use Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib, and dexamethasone, for treating multiple myeloma (MM) in patients who have received at least one prior therapy.

The EC initially granted marketing authorization to Darzalex in May 2016 for use as monotherapy in treating relapsed and refractory MM. Darzalex targets CD38, a surface protein expressed across MM cells, regardless of disease stage, according to Janssen. Janssen gained daratumumab, the active ingredient in Darzalex, from Genmab in an August 2012 worldwide agreement that granted Janssen an exclusive license to develop, manufacture, and commercialize daratumumab.

Source: Janssen-Cilag International 

FDA OKs Two Indications for Novartis’ Anti-Cancer Drug
The US Food and Drug Administration (FDA) has approved Novartis’ anti-cancer drug, Rydapt (midostaurin) for two indications. The first indication is in combination with chemotherapy for treating acute myeloid leukemia (AML) and the second indication is for treating advanced systemic mastocytosis (SM), a rare blood disorder.

In the AML indication, Rydapt is specifically approved for treating AML in newly diagnosed patients who are FMS-like tyrosine kinase 3 mutation-positive (FLT3+), as detected by an FDA-approved test. In the second indication, Rydapt is specifically approved for treating adults with advanced SM, which includes aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, and mast cell leukemia. This approval follows a prior breakthrough therapy designation in FLT3-mutated AML, as well as orphan drug designation and priority review in both indications by the FDA. Worldwide filings for Rydapt are currently underway.

Rydapt is an oral, multi-targeted inhibitor of multiple kinases, including FLT3 and KIT, that interrupts cancer cells’ ability to grow and multiply, according to Novartis.

Source: Novartis

FDA OKs New Dosing Option for Sanofi’s Anti-Cholesterol Drug
Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, have received approval from the US Food and Drug Administration (FDA) for the companies’ supplemental biologics license application for a once-monthly 300-mg dose of Praluent (alirocumab) injection for treating high low-density lipoprotein (LDL) cholesterol. The monthly 300-mg dose option was also approved by the European Commission in November 2016.

Praluent, a proprotein convertase subtilisin/kexin type 9 inhibitor, is approved in more than 50 countries worldwide, including the US, Japan, Canada, Switzerland, Mexico, Brazil, and the European Union (EU). In the US, Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for treating patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol. In the EU, Praluent is approved for treating patients with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet in combination with a statin, or statin with other lipid-lowering therapies, or alone or in combination with other lipid-lowering therapies.

Source: Regeneron Pharmaceuticals

EC Grants Conditional Approval for Shire’s Parathyroid Drug
The European Commission has granted conditional marketing authorization to Shire for Natpar (recombinant human parathyroid [1-84]) as adjunctive treatment for chronic hypoparathyroidism.

With this approval, Shire is now authorized to market Natpar in the 28 member states of the European Union (EU), as well as in Iceland, Liechtenstein, and Norway. In the US, Natpar is approved under the trade name Natpara (parathyroid hormone).

Source: Shire

Takeda Gains FDA OK for Lung Cancer Drug
Takeda Pharmaceutical has received accelerated approval from the US Food and Drug Administration (FDA for Alunbrig (brigatinib) for treating anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) in patients who have progressed on or are intolerant to crizotinib. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Alunbrig is a targeted cancer medicine discovered by Ariad Pharmaceuticals, a Cambridge, Massachusetts-headquartered pharmaceutical company that Takeda acquired in February 2017 for approximately $5.2 billion. The drug has the potential to reach peak annual sales of more than $1 billion, according to Takeda.

Alunbrig received breakthrough therapy designation from the FDA for this indication and was granted orphan drug designation for treating ALK+, ROS1+, and epidermal growth factor receptor positive NSCLC. A marketing authorization application was submitted to the European Medicines Agency in February 2017.

Source: Takeda Pharmaceutical

Teva, Impax Launch Generics of Merck & Co.’s Anti-Cholesterol Drug
Teva Pharmaceutical Industries and Impax Laboratories, a Hayward, California-headquartered specialty pharmaceutical company, have individually launched their generic versions of Merck & Co.’s Vytorin (ezetimibe/simvastatin), an anti-cholesterol drug, in the US. Merck’s Vytorin (marketed as Inegy outside the US) had 2016 sales of $473 million in the US and $1.14 billion globally. Vytorin is a combination of Merck’s older statin drug, simvastatin, and ezetimibe, also a cholesterol-lowering agent.

Ezetimibe and simvastatin tablets are indicated for reducing elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, triglycerides, and non-high-density lipoprotein cholesterol in addition to increasing high-density lipoprotein cholesterol in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.

In addition to Teva and Impax, Dr. Reddy’s Laboratories has also launched its generic version of Vytorin in the US, ezetimibe and simvastatin tablets in 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg dosage forms.

Source: Teva Pharmaceutical IndustriesImpax Laboratories, and Dr. Reddy’s Laboratories

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