Xconomy Indiana
Eli Lilly is preparing to file again for FDA approval of rheumatoid arthritis drug baricitinib (Olumiant) by the end of Januarythis time with new information about the drugs safety and efficacy.
The FDA rejected the Indianapolis pharmaceutical companys initial drug application in April. In July, Lilly (NYSE: LLY) said discussions with the regulator included the possibility of requiring an additional study. Lilly said the FDA had expressed concern about blood clots observed during clinical trials and it asked the company to provide more information about dosing and safety.
Lilly will now try to provide the data that the FDA wants without conducting another study. The company said Wednesday that its new January goalmonths earlier than the 18-month delay that the company forecast in Julywas set after additional discussions with the regulator late this month. The filing will be a Class 2 resubmission, an agreement between a company and the FDA to start a six-month review cycle for a drug after the FDA receives the application. Under that timeline, an FDA decision could come by the end of July 2018.
Rheumatoid arthritis is an autoimmune disorder in which the immune system mistakenly attacks joint tissues, causing swelling and pain. Baricitinib is a once-daily pill that blocks proteins associated with this inflammation. In 2009, Lilly licensed global rights to the drug from Wilmington, DE-based Incyte (NASDAQ: INCY).
The European Commission approved baricitinib in February. That month, the New England Journal of Medicine published results from a Phase 3 clinical trial that compared the Lilly drug to adalimumab (Humira), an injectable biologic drug that generates blockbuster sales for AbbVie (NYSE: ABBV). Baricitinib beat AbbVies drug in the study, and Lilly was widely expected to win FDA approval.
In the months following the FDAs surprise rejection of baricitinib, regulators in Europe have agreed to update the drugs label with additional warnings for patients at risk for deep vein thrombosis and pulmonary embolism. Baricitinib was approved in Japan last month. Lilly says that the drugs label in that country includes precautions about the cardiovascular risks.
Photo by Flickr user tr0tt3rvia a Creative Commons license.
Frank Vinluan is editor of Xconomy Raleigh-Durham, based in Research Triangle Park. You can reach him at fvinluan [at] xconomy.com
Read more here:
Eli Lilly Preps Rejected Rheumatoid Arthritis Drug for Resubmission - Xconomy
- Annual Health Observances | NIAMS - National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) - October 6th, 2024
- Obesity dampens rheumatoid arthritis treatment effectiveness, satisfaction - Healio - October 6th, 2024
- Patient Perspectives: Finding Grace While Living With Rheumatoid Arthritis - Rheumatology Advisor - October 6th, 2024
- Rheumatoid arthritis tied to heavy economic and human burdens - Medical Xpress - October 6th, 2024
- Dual therapy can have synergistic effect in difficult-to-treat inflammatory diseases - Healio - October 6th, 2024
- Hand-Held Scanner Could Transform Cancer and Arthritis Diagnosis - Technology Networks - October 6th, 2024
- Medical imaging breakthrough could transform cancer and arthritis diagnosis - University College London - October 6th, 2024
- Citryll and leading rheumatology centres receive - GlobeNewswire - October 6th, 2024
- Its going to be ubiquitous: Weight loss drugs may aid rheumatic disease treatment - Healio - October 6th, 2024
- Comorbidities Associated With Psoriasis: 5 Things to Know - Medscape - October 6th, 2024
- Opinion: Let's treat arthritis with the seriousness it deserves - Vancouver Sun - October 6th, 2024
- New handheld scanner technology could transform cancer and arthritis diagnosis - The Engineer - October 6th, 2024
- Stem cell therapy for osteoarthritis: Functional cartilage regeneration using 3d bioprinting technology - Open Access Government - October 6th, 2024
- Handheld scanner could transform cancer and arthritis diagnosis study - The Independent - October 6th, 2024
- Ankylosing Spondylitis and Self-Care: 6 Science-Backed Tips - Everyday Health - October 6th, 2024
- From a Labrador with arthritis to a goldfishs lifespan your pet queries answered... - The Sun - October 6th, 2024
- 15 Home Essentials That Make Life Easier If You Have Arthritis - HuffPost - September 21st, 2024
- Gout, a painful form of arthritis, is on the rise. Avoiding red meat and alcohol can help. - Yahoo Life - September 21st, 2024
- Arthritis Can Flare Up in Colder Weather: Tips to Easing the Pain - MedicineNet - September 21st, 2024
- Arthritis Can Flare Up in Colder Weather: Tips to Easing the Pan - U.S. News & World Report - September 21st, 2024
- Arthritis can flare up in colder weather: Tips to easing the pan - Medical Xpress - September 21st, 2024
- See how Waymo is bringing Arthritis Foundation of Arizona families to the ballpark - ABC15 Arizona in Phoenix - September 21st, 2024
- Prevalence of Loneliness in Inflammatory Arthritis and its Association with Disease Activity - Physician's Weekly - September 21st, 2024
- Psoriatic Arthritis and Gluten: Whats the Link? - Health Central - September 21st, 2024
- Arthritis Can Flare Up in Colder Weather: Tips to Easing the Pan - Southernminn.com - September 21st, 2024
- 6 Knee Injuries That Can Cause Arthritis - Health News Hub - September 21st, 2024
- The Best Rheumatoid Arthritis Self-Care Tips To Soothe Painful Joints and Improve Mobility - Yahoo Life - September 21st, 2024
- Arthritis Can Flare Up in Colder Weather: Tips to Easing the Pan - El Paso Inc. - September 21st, 2024
- Shifting kneecap in kids? Early ligament repair can prevent arthritis in young Age: Experts - The Times of India - September 21st, 2024
- Arthritis Can Flare Up in Colder Weather: Tips to Easing the Pan - Shelbynews - September 21st, 2024
- Arthritis Can Flare Up in Colder Weather: Tips to Easing the Pan - Citizentribune - September 21st, 2024
- Arthritis Can Flare Up in Colder Weather: Tips to Easing the Pan - News-Daily.com - September 21st, 2024
- Casavant: Access to virtual care at risk for millions of arthritis patients - Daily Independent - September 21st, 2024
- Arthritis Can Flare Up in Colder Weather: Tips to Easing the Pan - Avery Journal Times - September 21st, 2024
- Arthritis Can Flare Up in Colder Weather: Tips to Easing the Pan - The Elkhart Truth - September 21st, 2024
- What To Eat (And Skip) on a Rheumatoid Arthritis Diet To Reduce Painful Inflammation - Woman's World - September 21st, 2024
- Tiny knee bone linked to arthritis may have helped humans walk upright, scientists suggest - Sky News - September 13th, 2024
- Medical Marijuana Helps People With Arthritis And Other Rheumatic Conditions Reduce Use Of Opioids And Other Medications, Study Shows - Marijuana... - September 13th, 2024
- My 'stomach bug' turned out to be an agonising pain condition that left me wheelchair bound within four years - Daily Mail - September 13th, 2024
- Distinct mucosal endotypes as initiators and drivers of rheumatoid arthritis - Nature.com - September 13th, 2024
- Early Use of Steroids Linked to Prolonged Treatment in RA - Medscape - September 13th, 2024
- How rheumatoid arthritis and Down syndrome are helping researchers find treatments for Alzheimer's - Colorado Public Radio - September 13th, 2024
- Is It Bad to Drink Coffee if You Have Rheumatoid Arthritis? - Health Central - September 13th, 2024
- Harnessing Patient Insights: The Role of PROs in Managing Psoriasis and Psoriatic Arthritis - MD Magazine - September 13th, 2024
- Spotlight On Maryland-The Arthritis Foundation - Audacy - September 13th, 2024
- Gum disease and arthritis: How bacteria in your mouth could be hurting your joints - Hindustan Times - September 13th, 2024
- An interdisciplinary perspective on peripheral drivers of pain in rheumatoid arthritis - Nature.com - September 13th, 2024
- Sky's Angel Reese to have wrist surgery Tuesday, be in cast for six weeks - USA TODAY - September 13th, 2024
- A message from AdventHealth: Swing into action to fight Arthritis - Johnson County Post - September 13th, 2024
- Bio-Thera Solutions and Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCE (BAT1806/BIIB800), an approved Biosimilar referencing tocilizumab in... - September 13th, 2024
- Failed Remission in Early RA No Better With Added Etanercept - Medscape - August 25th, 2024
- Trapeziectomy and Mini TightRope Suspensionplasty for First Carpometacarpal Joint Arthritis - Cureus - August 25th, 2024
- What is early arthritis? UAB experts weigh in - University of Alabama at Birmingham - August 25th, 2024
- Evaluating and Adjusting Rheumatoid Arthritis Treatment: Adhering to ACR Guidelines for csDMARDs and Advanced Therapies - MD Magazine - August 25th, 2024
- Gelsolin alleviates rheumatoid arthritis by negatively regulating NLRP3 inflammasome activation - Nature.com - August 25th, 2024
- The association between the aggregate index of systemic inflammation and risk of rheumatoid arthritis: retrospective analysis of NHANES 19992018 -... - August 25th, 2024
- High Prevalence of Tendon Issues in Hand Osteoarthritis - Medscape - August 25th, 2024
- The point of knee shots - Harvard Health - August 25th, 2024
- Exploring the Discrepancy Between Patient Perception and Disease Activity Assessments - MD Magazine - August 25th, 2024
- Do you have knee pain from osteoarthritis? You might not need surgery. Here's what to try instead - ABC News - August 25th, 2024
- Blood test provides early alert to knee arthritis - Cleveland Jewish News - August 7th, 2024
- Lifestyle tips for youth's bone health: Avoid these habits to prevent arthritis - Hindustan Times - January 25th, 2024
- Arthritis | Johns Hopkins Medicine - January 9th, 2024
- What Is Arthritis? | Arthritis Foundation - May 17th, 2023
- Procedure to Surgery for Arthritis Is Recommended After First Failed Non-Operative Therapy - DocWire News - March 29th, 2023
- Higher Prevalence of Sarcopenia Reported in Patients with Rheumatoid Arthritis - Rheumatology Network - October 7th, 2022
- Exploring the Relationship Between Psoriatic Arthritis and Psoriasis - Dermatology Times - October 7th, 2022
- Are Tomatoes Bad For Arthritis? Here's What An MD Has To Say - Women's Health - October 7th, 2022
- Tocilizumab for Treating ICI-Induced Arthritis and Colitis - DocWire News - October 7th, 2022
- Why Arthritis Is A Clear And Present Danger, And How We Can Fight It - CNBCTV18 - October 7th, 2022
- Arthritis: Five cruciferous veg 'block inflammatory process' - backed by 10-year study - Express - October 7th, 2022
- 5 Exercise Habits for Arthritis in Your 50s - Eat This, Not That - October 7th, 2022
- Arthritis: 8 types of fish can cause acid crystals to build up in joints - 'very painful' - Express - October 7th, 2022
- EMA Issues Positive Opinion on the Safety of Filgotinib - Medscape - October 7th, 2022
- Lamb of God's Willie Adler on their new album Omens - Guitar.com - October 7th, 2022
- Eat Your Way to Stronger Bones & Healthy Joints - Daniel Island News - October 7th, 2022
- Long COVID could be linked to a totally different (and common) virus, new study finds - Fortune - October 7th, 2022
- My body hurt so much I thought I had arthritis & I started forgetting people it was the menopause, says K... - The Sun - October 7th, 2022
- 'Terrified' nan cant afford heating despite painful arthritis and will do 'Christmas shopping at Poundland' - Lincolnshire Live - October 7th, 2022
- Dirt & Glory's Alex Moss Cherishes the 'Real World Impact' of His Role | LBBOnline - Little Black Book - LBBonline - October 7th, 2022