Chain Drug Review, March 16th, 2020
BRANDED DRUGS Retail Pharmacy Approval Nears for MS Drug Focus BASEL Switzerland The Food and Drug Administration and European Medicines Agency have accepted Novartis Supplemental Biologics License Application sBLA and Marketing Authorization Application MAA respectively for ofatumumab OMB157 for the treatment of relapsing forms of multiple sclerosis RMS in adults Ofatumumab is a novel Bcell therapy that delivers sustained efficacy with a favorable safety profile If approved ofatumumab has the potential to become a first choice treatment for a broad RMS population and the first B cell therapy that is easy to start and manage in a monthly subcutaneous injection that can be self administered at home using an autoinjector pen The regulatory applications are based on positive data from the Phase III ASCLEPIOS I and II studies which investigated the efficacy and safety of monthly subcutaneous ofatumumab 20 mg versus once daily oral Aubagio teriflunomide 14 mg in adults with RMS In both headto head studies ofatumumab demonstrated superiority over Aubagio in patients with RMS Both studies met the primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses evaluated as the annualized relapse rate ARR Key secondary endpoints of delaying time to confirmed disability progression CDP were also met Data presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis ECTRIMS showed that compared to Aubagio ofatumumab Reduced the ARR by 505 011 versus 022 and 585 010 versus 025 p 0001 in both studies in ASCLEPIOS I and II respectively Showed highly significant suppression of both Gd T1 lesions and new or enlarging T2 lesions demonstrating a profound abrogation of new inflammatory activity Showed a relative risk reduction of 344 p 0002 in three month CDP and 325 p 0012 in six month CDP in prespecified pooled analyses Overall ofatumumab a potent fully human antibody targeting CD20 positive B cells delivered efficacy with a favorable safety profile The safety profile of ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results The potential to be a powerful first choice treatment option for patients and physicians In addition Novartis has completed the APLIOS study an open label Phase II study to determine the bioequivalence of subcutaneous administration of ofatumumab via a prefilled syringe as used in ASCLEPIOS I and II and an autoinjector pen in patients with RMS The positive results of the study will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis ACTRIMS Forum in Florida These results show that ofatumumab offers a highly effective B cell therapy that can be self administered at home using a patient friendly autoinjector pen We are excited that ofatumumab has the potential to be a powerful firstchoice treatment option for patients and physicians looking for an impactful intervention said Krishnan Ramanathan neuroscience global program head at Novartis With ofatumumab we underpin our relentless dedication to reimagine medicine for patients across the MS spectrum and will work closely with the regulatory authorities to ensure it is available for people living with MS as soon as possible Regulatory approval for ofatumumab in the U S is expected in June and in Europe by the second quarter of next year Novartis is committed to bringing ofatumumab to patients worldwide and additional regulatory filings are currently under way Ofatumumab works by binding to the CD20 molecule on the B cell surface distinct from that of other anti CD20 antibodies and induces potent Bcell lysis and depletion The selective mechanism of action and subcutaneous administration of ofatumumab allows precise delivery to the lymph nodes where B cell depletion in MS is needed while sparing those in the spleen that help maintain protective immunity Once monthly dosing of ofatumumab also allows faster repletion of B cells and offers more flexibility as no first dose observations or laboratory monitoring are required Novartis obtained rights for ofatumumab from Genmab in all indications including MS in December 2015 The ASCLEPIOS I and II studies are twin identical design flexible duration up to 30 months double blind randomized multi center Phase III studies evaluating the safety and efficacy of ofatumumab 20 mg monthly subcutaneous injections versus Aubagio 14 mg oral tablets taken once daily in adults with RMS The studies enrolled 1882 patients with MS between the ages of 18 and 55 with an Expanded Disability Status Scale EDSS score between 0 and 552 The studies were conducted in over 350 sites in 37 countries Rx Update Lilly Completes Dermira Deal Eli Lilly and Co announced the successful completion of its acquisition of Dermira The acquisition expands Lillys immunology pipeline with the addition of lebrikizumab a novel investigational monoclonal antibody designed to bind IL 13 with high affinity that is being evaluated in a Phase 3 clinical development program for the treatment of moderate to severe atopic dermatitis in adolescent and adult patients 12 years old and older The acquisition of Dermira also expands Lillys portfolio of marketed dermatology medicines with the addition of Qbrexza glycopyrronium a medicated cloth approved by the Food and Drug Administration for the topical treatment of primary axillary hyperhidrosis uncontrolled excessive underarm sweating Esperion Announces FDA Approval of Nexletol Esperion announced that the Food and Drug Administration has approved Nexletol bempedoic acid tablet an oral once daily non statin LDL cholesterol LDL C lowering medicine Nexletol is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia HeFH or established atherosclerotic cardiovascular disease ASCVD who require additional lowering of LDL C The effect of Nexletol on cardiovascular morbidity and mortality has not been determined It is the first oral once daily non statin LDL C lowering medicine approved since 2002 for indicated patients FDA Grants Priority Review to Brigatinib Takedas Alunbrig or brigatinib which targets anaplastic lymphoma kinase genetic mutations was granted priority review status by the Food and Drug Administration as a first line treatment for ALK positive metastatic nonsmall cell lung cancer Nimble Working With Genentech Nimble Therapeutics announced a multiyear collaboration with Genentech a member of the Roche Group to accelerate discovery and development of novel peptide based medicines for targets across a range of diseases The collaboration will leverage Nimbles proprietary peptide synthesis screening and optimization platform chemical diversity and integrated suite of assays to enable faster discovery and optimization of promising compounds for intracellular and extracellular targets Under the terms of the agreement Nimble will receive an undisclosed up front payment and will be eligible for downstream milestone payments and royalties Merck Targets HIF 2 A therapy has been developed by Merck to target a molecular driver called hypoxia inducible factor 2 which was previously believed to be unresponsive to drugs in renal cell carcinoma FDA Grants Breakthrough Status The antibody drug conjugate PADCEV or enfortumab vedotin ejfv which is being developed by Seattle Genetics and Astellas Pharma in combination with Mercks Keytruda or pembrolizumab was granted Breakthrough Therapy designation by the Food and Drug Administration The regimen is being evaluated for patients with metastatic urothelial or unresectable locally advanced cancer who arent able to undergo cisplatin based chemotherapy as a first line treatment Sanofi to Spin Off New Company Sanofi said it would spin off a new company that will create the active chemical ingredients for drugs expanding into a market currently dominated by firms in China and India Sanofi plans an initial public offering for the new firm which will be based in France and is forecast to have sales of 1 billion euros in 2022 Flowonix Gets Green Light Flowonix Medical announced Food and Drug Administration approval to market the Prometra II Programmable Pump System for use with intrathecal baclofen Flowonix introduced the Prometra II 40 ml pump to the U S market in November 2019 providing patients and clinicians a choice between 20 ml and 40 ml capacities when choosing an intrathecal pump delivery device The new indication expands the market significantly for the Prometra device by enabling its use in the treatment of spasticity The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of drug therapy Kowa Randomizes 10000 Subjects RESEARCH TRIANGLE PARK N C Kowa Research Institute Inc has achieved its goal of randomizing 10000 subjects into its international multicenter Phase 3 cardiovascular outcomes trial for K 877 pemafibrate Titled Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes PROMINENT the trial is evaluating triglyceride reduction and increasing functional HDL with the drug in high risk patients with diabetes with high triglyceride and low HDL C levels who are already taking statins All PROMINENT participants receive aggressive standard of care management of cardiovascular risk factors including treatment with high intensity statins In addition patients receive either K 877 or placebo The trial includes patients with high triglycerides and low HDL with diabetes with and without established cardiovascular disease and will test whether K 877 reduces the occurrence of heart attacks hospitalizations for unstable angina requiring unplanned revascularization stroke or death from cardiovascular causes Dr Paul Ridker director of the Center for Cardiovascular Disease Prevention CCVDP at Brigham and Womens Hospital BWH a teaching affiliate of Harvard Medical School and Dr Aruna Pradhan a cardiologist at BWH are co principal investigators of the trial We are pleased to have achieved our goal to randomize 10000 patients into PROMINENT said Dr Gary Gordon president of the Kowa Research Institute Cardiovascular disease remains the No 1 cause of death worldwide We will maintain focus on ensuring this important study is completed as planned to determine whether K 877 can be a new valuable tool for physicians managing patients cardiovascular disease K 877 is a highly potent and selective peroxisome proliferator activator receptor alpha PPAR alpha modulator SPPARMalpha a promising category of metabolic therapy Evidence supports a role for triglyceride rich lipoproteins and low HDL C as important contributors to atherosclerosis Kowa set out to create the most potent and selective PPAR modulator ever developed and succeeded with K 877 which is at least 1000 times as potent and selective as other drugs Kowa has launched pemafibrate for hyperlipidemia in Japan under the brand name Parmodia Kowas clinical studies have shown K 877 significantly reduces triglycerides ApoC3 and remnant cholesterol and increases functional HDL and FGF21 Chain Drug Review March 16 2020 67
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