New Drug Report 2020 -10

The Janus kinase (JAK1) inhibitor Figotinib (Jyseleca; Gilead) was approved in Japan and the European Union in September 2020. The approved indication in Japan is the treatment of patients with rheumatoid arthritis (RA) who do not respond to conventional treatments (including the prevention of structural joint damage). The indication approved in the European Union is the treatment of moderately to severely active RA adult patients with insufficient response or intolerance to one or more disease-relieving anti-rheumatic drugs (DMARDs), which can be used as monotherapy or combined with methotrexate. Figotinib was first launched in Germany in mid-October 2020.

Another new drug for the treatment of rheumatoid arthritis is the anti-IL-6 monoclonal antibody Olozumab (Artlegia; R-Pharm), which was approved in Russia last year. The biological agent was discovered by UCB and licensed to R-Pharm in 2013 for development and commercialization. The drug obtained positive results in the CREDO International Phase III clinical trial project. Last fall, R-Pharm announced the results of the CREDO-1 study at the annual meeting of the American Academy of Rheumatology. The results showed that Olozumab had a good effect on the quality of life, work efficiency and fatigue relief of moderate to severe RA patients who have failed previous methotrexate treatment.

Consensi is a fixed-dose combination of COX-2 inhibitor celecoxib and calcium channel blocker amlodipine besylate. It was first launched in the United States last year. Kitov Pharma has developed a new combination therapy to treat patients who are suitable for the use of amlodipine for hypertension and celecoxib for osteoarthritis. The drug was listed by Burke Therapeutics.

In December last year, the FDA approved two new drugs for the treatment of extremely rare autoimmune diseases: interleukin-1 receptor antagonist deficiency (DIRA). DIRA is caused by mutations in the IL1RN gene encoding the interleukin-1 receptor antagonist (IL-1Ra) protein. DIRA usually develops in infancy and is characterized by painful and life-threatening inflammation of the skin and bones, severe chronic pain, and growth retardation.

The approval of the recombinant human interleukin-1 receptor antagonist Anakinra (Kineret; Sobi) was based on a long-term natural history study evaluating the safety and effectiveness of Anakinra. The study included 9 patients with DIRA diagnosed by genetic testing (age from one month to 9 years old at the time of treatment), and these patients have been treated with the drug for up to 10 years. In the 6 patients who reported the dose, the starting dose of Anakinra was 1-2 mg/kg per day (the other three patients did not report the starting dose). Then researchers adjusted the dose according to individual conditions to achieve a stable dose that can effectively control active inflammation. During the treatment with Anakinra, the inflammation of all 9 patients was relieved. Inflammation relief is defined as the return of C-reactive protein levels to normal levels (≤5mg/L), no signs and symptoms of impetigo or inflammatory bone disease, and no discontinuation of glucocorticoids during the use of Anakinra. The most common adverse events in DIRA patients were upper respiratory tract infection, skin rash, fever, flu-like symptoms, and gastroenteritis. The safety profile was consistent with that of the drug in the treatment of neonatal-onset multi-system inflammatory disease (NOMID), a previously approved indication. Anakinra was originally approved by the FDA in 2001 for the treatment of moderate to severe active rheumatoid arthritis, and was approved for the treatment of NOMID in 2013.

In December 2020, the FDA approved a supplementary biological product license application (sBLA) submitted by Kiniksa for Arcalyst for the treatment of DIRA. Linazep is a dimeric fusion protein consisting of a ligand binding domain outside the human interleukin-1 receptor antagonist (IL-1RI) and an IL-1 receptor accessory protein (IL-1RAcP) in series with the Fc fragment of human IgG1. Since its launch in 2008, Linazep has been used to treat cyclic syndrome associated with cold pyridine, and the drug has been identified as an orphan drug for the treatment of these two indications.

15 Ophthalmic drugs

Etopranol (Eysuvis) is a topical corticosteroid that was approved by the FDA last year for a new indication, namely dry eye. The drug is a corticosteroid designed according to the reverse metabolism idea. It has been used to treat other eye diseases for 20 years and has good safety characteristics (42). This new dosage form of Etopranol was developed by Kala Pharmaceuticals, based on the new indication of dry eye (short-term treatment, up to 2 weeks) form the favorable result of STRIDE-1, STRIDE-2 and STRIDE-3 studies (NCT02819284, NCT02813265 and NCT02188160), and the NDA application was filed in the United States. The preparation is a nanosuspension made using AMPPLIFY® mucus penetrating particles (MPP) drug delivery technology. It was launched in December 2020 and became the first ophthalmic corticosteroid drug approved by the FDA for the treatment of dry eye.

16 Therapeutic drugs for poisoning and drug abuse

Baclocur (Ethypharm), a GABA-B receptor agonist approved in France for a new indication of alcoholism in 2018, would finally be on the market in early 2020. The drug was first marketed in the 1970s for the treatment of spasms. Based on more than ten years of research, Baclofen tablets (10mg, 20mg, 30mg and 40mg) were approved in 2018 for the treatment of adult patients with alcoholism who are at high risk of alcohol dependence. However, only a few months later, multiple-strength preparations were withdrawn from the market; sales of 30mg-strength preparations were suspended.