AbbVie, Bristol-Myers Squibb, and Roche Lead Pipeline News
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AbbVie, Bristol-Myers Squibb, Gilead, Roche, and Shire.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday January 18, 2017 to Tuesday January 24, 2017.
EMA Accelerates Review of AbbVie’s Hep C Combo Regimen
AbbVie’s marketing authorization application (MAA) for the company’s investigational hepatitis C combination drug regimen, G/P (glecaprevir/pibrentasvir), has been validated and is now under accelerated assessment by the European Medicines Agency (EMA). AbbVie is seeking approval for G/P for treating all major chronic hepatitis C virus (HCV) genotypes.
The specific indication AbbVie is seeking is for treating HCV genotypes 1-6 patients without cirrhosis. If approved, G/P may also be an additional treatment option to patients with compensated cirrhosis. The drug regimen is also intended to address patients with specific treatment challenges, including severe chronic kidney disease, and those not cured with previous direct-acting antiviral treatment.
The EMA’s Committee for Medicinal Products for Human Use will review the G/P regimen under accelerated assessment. Validation of the MAA confirms that the submission is complete and starts the EMA’s centralized review process. If approved, AbbVie’s G/P regimen could be available for marketing in the European Union in the second half of 2017.
AbbVie also filed a new drug application for G/P in December 2016 with the US Food and Drug Administration seeking approval for the same HCV indication. In addition, AbbVie remains on track to submit a new drug application for G/P in Japan in the first quarter of 2017.
BMS Drops Pursuit of Combo Lung Cancer Therapy
Bristol-Myers Squibb (BMS) has decided not to pursue an accelerated regulatory pathway for the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) in first-line lung cancer in the US based on a review of data available at this time. The company did not provide additional details in order to protect the integrity of ongoing registrational studies.
BMS’ Opdivo is a programmed death (PD)-1 inhibitor and has regulatory approval in 60 countries, including the US, Japan, and in the European Union, according to BMS. In the US, Opdivo is indicated for treating BRAF V600 mutation-positive unresectable or metastatic melanoma, wild-type unresectable or metastatic melanoma, unresectable or metastatic melanoma in combination with Yervoy (ipilimumab), metastic non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, and recurrent or metastatic squamous cell carcinoma of the head and neck. The drug had 2015 sales of $942 million and has been pegged by some analysts as having blockbuster potential.
Source: Bristol-Myers Squibb
EMA Validates Gilead’s Combo Hep C Drug Application
The European Medicines Agency (EMA) has validated a marketing authorization application from Gilead Sciences for Gilead’s investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for treating chronic hepatitis C virus (HCV)-infected patients.
SOF/VEL/VOX for treating HCV will be reviewed by the EMA under the centralized licensing procedure for all 28 member states of the European Union as well as Norway and Iceland.
Gilead previously submitted a new drug application to the US Food and Drug Administration for SOF/VEL/VOX in this indication in December 2016.
Source: Gilead Sciences
FDA Grants Priority Review to Roche’s Arthritis Drug in New Indication
The US Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental biologics license application submitted by Genentech, a Roche company, for its anti-arthritis drug, Actemra (tocilizumab), for treating giant cell arteritis (GCA), a chronic autoimmune condition and a form of vasculitis.
Actemra is a humanized interleukin-6 (IL-6) receptor antagonist approved for treating moderately to severely active rheumatoid arthritis. Actemra is also used as an intravenous formulation for patients with active polyarticular juvenile idiopathic arthritis or patients two year of age and older with systemic juvenile idiopathic arthritis. In October 2016, Genentech received breakthrough therapy designation from the FDA for Actemra for treating GCA.
Actemra is part of a co-development agreement with Chugai Pharmaceutical, a Tokyo-based subsidiary of Roche, and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland, and Australia.
FDA Accepts Shire’s Resubmitted Application for ADHD Drug
The US Food and Drug Administration (FDA) has acknowledged receipt of a Class 2 resubmission of a new drug application (NDA) from Shire for SHP465, a long-acting, triple-bead, mixed-amphetamine salts formulation. SHP465 is being evaluated as a potential once-daily treatment for attention-deficit/hyperactivity disorder (ADHD).
The FDA is expected to provide a decision on or around June 20, 2017, the designated Prescription Drug User Fee Act action date. Shire resubmitted the NDA in response to an approvable letter from the FDA in May 2007 requesting additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.
Patent protection for Shire’s overall ADHD franchise is extended to 2029. If approved, Shire expects that SHP465 will have three years of Hatch-Waxman exclusivity and at least three patents listed in the FDA Orange Book expiring as late as May 2029. Launch is planned for the second half of 2017.
UCB Files for New Indication for Epilepsy Drug
UCB, a Brussels, Belgium-based biopharmaceutical company, has filed a supplemental new drug application to the US Food and Drug Administration for Briviact (brivaracetam) controlled substance as monotherapy for treating the partial-onset of seizures in patients 16 years of age and older with epilepsy.
Briviact is currently approved in the US and European Union as adjunctive therapy for treating partial-onset seizures in patients 16 years of age and older with epilepsy. Brivaracetam, the active ingredient in Briviact, is not currently approved as monotherapy. Briviact is available in three formulations: film-coated tablets, oral solution, and injection.