Novartis, Johnson & Johnson, GlaxoSmithKline, Shire, and Roche Led Drug Approval News
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A roundup of the latest drug approval news, including from the pharmaceutical majors, featuring news from Novartis, Johnson & Johnson, GlaxoSmithKline, Shire, and Roche.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday June 28, 2017 to Tuesday July 11, 2017.

Sanofi Receives EU OK for Rheumatoid Arthritis Drug
Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, have been granted marketing authorization from the European Commission for Kevzara (sarilumab), a human monoclonal antibody, in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis (RA).

This indication is for adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs such as MTX. Kevzara may be used as monotherapy in case of intolerance to MTX or when treatment with methotrexate is inappropriate.

Kevzara binds to the interleukin-6 receptor (IL-6R) and blocks pro-inflammatory IL-6 mediated signaling. Elevated levels of IL-6 are found in the synovial fluid of patients with RA and play an important role in both the pathologic inflammation and joint destruction which are hallmarks of RA, according to information from Sanofi.

In May 2017, Kevzara was approved in the US to be marketed by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi. Kevzara was approved in Canada in January 2017.

Source: Sanofi


FDA Approves New Treatment for Sickle-Cell Disease
The US Food and Drug Administration (FDA) has approved from Emmaus Life Sciences, a biopharmaceutical company for rare and orphan disease, Endari (L-glutamine oral powder) for patients age five years and older with sickle-cell disease to reduce severe complications associated with the blood disorder.

Sickle-cell disease is an inherited blood disorder in which the red blood cells are abnormally shaped (in a crescent, or “sickle,” shape) that restricts the flow in blood vessels and limits oxygen delivery to the body’s tissues, leading to severe pain and organ damage.

Endari received orphan drug designation for this use, which provides incentives to assist and encourage the development of drugs for rare diseases. In addition, development of this drug was in part supported by the FDA Orphan Products Grants Program, which provides grants for clinical studies on safety and/or effectiveness of products for use in rare diseases or conditions.

Source: FDA


EC Approves Novartis’ Zykadia Treatment Expansion
The European Commission (EC) has approved expanding the use of Novartis’ Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.

The approval is applicable to all 28 European Union member states plus Iceland, Lichtenstein, and Norway.

In May 2017, the US Food and Drug Administration approved this expanded use of Zykadia to include the first-line treatment of patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Zykadia is an oral, selective inhibitor of anaplastic lymphoma kinase (ALK), a gene that can fuse with others to form an abnormal “fusion protein” that promotes the development and growth of certain tumors in cancers, including NSCLC, according to information from Novartis. Zykadia is currently approved in over 70 countries

Source: Novartis


FDA Grants Priority Review of New Use for J&J’s Anticoagulant Xarelto
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for Xarelto (rivaroxaban) by Johnson & Johnson’s Janssen Research & Development LLC to include a 10-mg once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy. This accelerated review advances the FDA’s Prescription Drug User Fee Act target date to October 28, 2017.

VTE includes deep vein thrombosis, a blood clot in a deep vein (often in the legs), and pulmonary embolism, a clot that travels to the lung.

Xarelto currently has six indications approved by the FDA, including the treatment of VTE (15 mg twice daily for the first 21 days followed by 20 mg once daily for the remainder of treatment), and reduction in the risk of recurrent VTE (20 mg once daily).

Rivaroxaban was discovered by Bayer HealthCare and is being jointly developed with Janssen. Xarelto is marketed outside the US by Bayer HealthCare and in the US by Janssen Pharmaceuticals, a Johnson & Johnson Company. Xarelto is approved in more than 125 countries.

Source: Janssen


EC Approves New Formulation for Roche’s Rare Lung Disease Drug
The European Commission (EC) has approved a new tablet formulation of Roche’s Esbriet (pirfenidone) for treating mild-to-moderate idiopathic pulmonary fibrosis (IPF), a condition that causes irreversible, progressive scarring of the lungs.

The new tablet formulation is available as an 801-mg or 267-mg tablet. This new formulation allows patients to take one tablet three times per day instead of three capsules three times per day. At equal doses, the new tablet formulation is bioequivalent to the currently available capsule version of Esbriet. In addition, the film-coated 267- mg tablet that has been introduced is smaller than the 267-mg capsule and might be easier to swallow.

The new Esbriet tablet formulation is already approved by the US Food and Drug Administration and available in the US. Roche expects to begin launching the tablet formulation in a number of European markets throughout 2017.

Esbriet was developed by InterMune, which Roche acquired in September 2014.

Source: Roche


GSK Submits sBLA to FDA for Rare-Disease Drug
GlaxoSmithKline (GSK) has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration, seeking approval of mepolizumab, an interleukin-5 (IL-5) antagonist, as an add-on therapy to corticosteroids for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).

EGPA is a rare disease, characterized by widespread inflammation in the walls of small blood vessels, which may lead to tissue and organ damage. The disease may affect multiple organ systems and be associated with symptoms of fatigue, muscle and joint pain and weight loss. 

Mepolizumab is already approved for use in the US, under the brand name Nucala, as add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala has also been approved for severe eosinophilic asthma in the European Union, Japan, and a number of other countries worldwide although the details of the indications may vary.

Regulatory filings in other countries are planned during the course of 2017 and 2018. Mepolizumab is not approved anywhere in the world for EGPA.

Source: GlaxoSmithKline


Shire Gets EMA Validation for Rare-Disease Drug
Shire has received the European Medicines Agency’s (EMA) validation of the marketing authorization application for Veyvondi (von Willebrand factor recombinant) to prevent and treat bleeding episodes and peri-operative bleeding in adults (age 18 and older) diagnosed with von Willebrand Disease (VWD), an inherited bleeding disorder. Currently, the drug is available in the US as Vonvendi.

Veyvondi is a VWF replacement therapy produced and formulated without the addition of any exogenous raw materials of human or animal origin, resulting in a product that contains only trace amounts of FVIII.

Vonvendi was approved by the US Food and Drug Administration in December 2015 and is indicated for on-demand treatment and control of bleeding episodes in adults with VWD. 

Shire is also seeking prophylaxis and pediatric indications for Vonvendi, with trials anticipated to conclude in 2019 and 2020, respectively.

Source: Shire


Amgen Receives FDA Approval for Cancer Drug
The US Food and Drug Administration has approved Amgen’s supplemental biologics license application for Vectibix (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer as first-line therapy in combination with FOLFOX, a chemotherapy regimen for treating colorectal cancer, and as monotherapy following disease progression after prior treatment with fluoropyrimidine,oxaliplatin, and irinotecan-containing chemotherapy.

As part of this new indication, the FDA approved a multigene, sequencing-based test to identify the RAS mutation status of a patient’s tumor. This companion diagnostic helps physicians identify patients that are more likely to benefit from treatment with Vectibix.

Source: Amgen


Pfizer Receives EC Approval for Leukemia Drug Besponsa
The European Commission (EC) has approved Pfizer’s Besponsa (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).

This indication includes treatment of adults with Philadelphia chromosome positive (Ph+) as well as Philadelphia chromosome negative (Ph-) relapsed or refractory B-cell precursor ALL. Adults with Ph+ relapsed or refractory CD22-positive B-cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor (TKI).

Besponsa received breakthrough therapy designation from the US Food and Drug Administration (FDA) in October 2015 for ALL. A biologics license application for Besponsa for treating adult patients with relapsed or refractory B-cell precursor ALL was accepted for filing and granted priority review by the FDA in February 2017. The Prescription Drug User Fee Act  goal date for a decision by the FDA is August 2017.

Besponsa originates from a collaboration between Pfizer and Celltech, now UCB. Under the agreement, Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule. Pfizer also collaborated with SFJ Pharmaceuticals Group, a Pleasanton, California-based pharmaceutical company, on the registrational program for Besponsa.

Source: Pfizer

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