Vientiane, Laos - April 8, 2024 - BigBear Pharma, a leading biopharmaceutical company focused on the development and commercialization of innovative cancer therapies, announced that Baricitinib has been approved by the Lao Ministry of Health. It will be sold under the brand name BARUDX. Lao Reg No.: 03L1083/24, 2mg; Lao Reg No.: 03L1084/24, 4mg.
Baricitinib is a selective, reversible JAK1 and JAK2 inhibitor taken orally once daily. It is currently under clinical development for the treatment of various inflammatory and autoimmune diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriasis, atopic dermatitis, systemic lupus erythematosus, ulcerative colitis (UC), alopecia areata, and others.
Indications
1. Rheumatoid Arthritis
Baricitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). Baricitinib tablets can be used in combination with methotrexate or other non-biologic DMARDs.
2. Alopecia Areata
Baricitinib is indicated for the treatment of severe alopecia areata in adult patients. It is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.
Dosage and Administration
1. Rheumatoid Arthritis
(1) Treatment with Baricitinib tablets should be initiated by physicians experienced in the diagnosis and treatment of rheumatoid arthritis. The recommended dose of Baricitinib is 2 mg once daily.
(2) A dose of 4 mg once daily may be considered for the following patients:
① Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to conventional DMARDs and still have an inadequate response after 3 months of treatment at the starting dose of 2 mg once daily;
② Patients with an inadequate response to tumor necrosis factor inhibitors (TNFi-IR).
2. Alopecia Areata
(1) The recommended dose of Baricitinib is 2 mg once daily. If response to treatment is insufficient, the dose may be increased to 4 mg once daily.
(2) For patients with near total or total hair loss, with or without significant loss of eyelashes or eyebrows, a dose of 4 mg once daily may be considered.
(3) When patients achieve an adequate response on 4 mg once daily, the dose should be reduced to 2 mg once daily.
Adverse Reactions
The most common adverse drug reactions (ADRs) with Baricitinib are upper respiratory tract infections, headache, elevated LDL cholesterol, herpes simplex, and urinary tract infections. Serious infections such as pneumonia and severe herpes zoster are occasionally seen in patients with rheumatoid arthritis.
About BigBear Pharma
BigBear Pharma, headquartered in Vientiane, the capital of Laos, is committed to drug research, development, production, and sales, providing high-quality, safe, and effective pharmaceutical products. With its outstanding expertise and innovation capabilities, BigBear Pharma has built a strong reputation in the Lao pharmaceutical market and actively participates in international pharmaceutical cooperation and exchanges.
