What is Pharma doing about Lupus?
Treating lupus is complicated and usually unique to the individual. From prednisone and Plaquenil to cancer drugs like Methotrexate, finding a drug that manages lupus symptoms can sometimes seem more like trial and error than a science. One of the biggest challenges for lupus warriors and their health team is the lack of new lupus drugs that have been approved by the FDA.
Before GSK released Benlysta, there hadn’t been an approved lupus drug in 40 years. So will it be decades before we see another promising lupus drug? Hopefully not! Today, most major pharmaceutical companies are working on developing new lupus drugs.
Pharma companies working on new lupus drugs
AstraZeneca is leading the pharma pack in terms of number of new lupus drugs in development. They are currently involved with 4 new lupus drugs: 2 drugs with Amgen and 2 with their subsidiary MedImmune. Three of the four drugs are early stage phase 1 drugs: the two drugs with Amgen, AMG 557 and AMG 570 and MEDI0700 from MedImmune.
Anifrolumab, the other drug from MedImmune, has moved the furthest along in the drug development process. The drug showed positive results in phase 2 clinical trials (which is when they start measuring the effectiveness of a drug) and has moved to phase 3 for SLE. The drug is also in phase 2 for lupus nephritis.
Johnson & Johnson
J&J’s current drug, Stelara (ustekinumab), which is approved to treat plaque psoriasis, Crohn’s, and psoriatic arthritis is in clinical trials to test its effectiveness in lupus (SLE). While this is not a new lupus drug, if Stelara proves to be effective, it provides another treatment option.There are also rumors that J&J might buy Actelion, which has a phase 2 lupus drug, Cenerimod.
Eli Lilly is working with Incyte on Baricitinib, also known as LY3009104, which is being studied for the treatment of SLE. Baricitinib is waiting for regulatory review for the treatment of Rheumatoid arthritis, and is also being studied to treat Atopic dermatitis, Diabetic nephropathies, and Psoriasis.
Biogen has 2 drugs in development for lupus: BIIB059 and Dapirolizumab pegol. BIIB059 is in phase 2 clinical trials for both CLE and SLE. Biogen is working with UCB pharma on Dapirolizumab pegol which is also in phase 2 of clinical trials.
Roche / Genentech
Roche and Genentech researching their drug Obinutuzumab for the treatment of lupus nephritis. Obinutuzumab is currently being marketed to treat Chronic lymphocytic leukemia and Non-Hodgkin’s lymphoma. The drug is in phase 2 clinical trials to test if it is an effective treatment for lupus nephritis. (Up to 60% of lupus patients will develop lupus nephritis.)
Abbvie is partnered with Ablynx Pharma on Vobarilizumab, aka ALX 0061 which is in phase 2 of clinical trials for SLE. The drug also showed promising results in phase 2 clinical trials for the treatment of Rheumatoid Arthritis.
Lulizumab, Lulizumab pegol, or BMS-931699 is a drug by Bristol-Myers Squibb that is being studied to treat SLE and Sjogren’s syndrome. The drug is in phase 2 of clinical trials for both lupus and Sjogren’s.
The makers of Benlysta don’t appear to have another lupus drug in the pipeline but have several clinical trials and studies focused on understanding the effectiveness of the Benlysta in lupus patients.
The well known pharmaceutical company that makes Lipitor and Celebrex is working on two early stage lupus drugs: PF-06823859 and PF-06650833. Both are early stage phase 1 drugs so there is still a lot that is unknown.
Merck recently reported positive results from its Phase 2 study of atacicept for SLE. The drug showed particularly good results in patients with high disease activity according to the study.