Innovative drugs introduced by CMS for the treatment of psoriasis are planned to be included in the priority review

ArticleMedicine Guanlan

According to the latest announcement by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, the methotrexate injection (prefilled) introduced by CMS is based on “the innovation of urgently needed clinically-needed drugs, imitation of key infectious diseases, rare diseases and other diseases.

Screenshot source: CDE official website

According to an earlier press release issued by CMS, methotrexate (MTX) is the first-line standard for systemic treatment of rheumatoid arthritis (RA), but oral methotrexate has greater gastrointestinal side effects and patients comply with it.

According to reports, the methotrexate prefilled syringe/injection pen (MTX-medac) is a low-dose and small-volume methotrexate injection of various specifications, allowing patients to self-administer subcutaneously

Previously, MTX-medac has been approved in Europe and the United States for the treatment of rheumatoid arthritis and other autoimmune diseases, such as polyarticular juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, Crohn Graciousness and so on

In June of this year, CMS received a drug clinical trial approval notice issued by NMPA, and agreed to MTX-medac to carry out clinical trials for adult rheumatoid arthritis indications

The MTX-medac is planned to be included in the priority review, and the indication is psoriasis

CMS recently pointed out in a press release that MTX-medac has been announced as a reference preparation (RLD) by China’s National Food and Drug Administration, and is expected to become China’s first subcutaneously administered methotrexate drug to treat psoriasis.

references:

[1] Center for Drug Evaluation (CDE) of China National Medical Products Administration.

[3] CMS and medac signed a license agreement for standard treatment products for the treatment of autoimmune diseases and bladder cancer.