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Text|Pharmaceutical Mission Hills
On September 13, Pfizer announced that the National Medical Products Administration (NMPA) of China has officially approved the marketing application of its oral JAK inhibitor tofacitib citrate sustained-release tablets for insufficient efficacy against methotrexate Or adult patients with moderate to severe active rheumatoid arthritis (RA) who cannot tolerate it can be used in combination with methotrexate or other non-biological disease-improving anti-rheumatic drugs (DMARD)
.
Tofacitinib is an oral JAK inhibitor that acts on the JAK pathway and blocks intracellular signaling related to moderate to severe active rheumatoid arthritis inflammation
.
Pfizer introduced tofacitib to China in 2017 (trade name: Shangjie), and the approved recommended dosage for its regular-release dosage form is 5mg each time, twice a day
Studies on the bioequivalence of tofacitinib sustained-release dosage forms and regular-release dosage forms show that the area under the curve (AUC) and peak concentration (Cmax) of tofacitinib sustained-release dosage forms of 11 mg once a day are comparable to those of tofacitinib regular-release dosage forms.
The dosage form is equivalent to 5 mg twice a day
.
When combined with a high-fat diet, AUC did not change, indicating that the clinical efficacy is not affected by food
In addition, the US CORRONA registry data proves that there is no significant difference in the main outcome of the clinical disease activity index (CDAI) improvement to the minimum clinically important difference (MICD) between the sustained-release formulation of tofacitib and the normal-release formulation
.
Tofacitinib sustained-release dosage form 11 mg once a day is convenient for oral treatment and administration, reduces the number of administrations, improves patient compliance, and effectively improves disease activity
Rheumatoid arthritis is a chronic, inflammatory autoimmune system disease that can cause a range of symptoms, including pain and swelling in the joints, especially the hands, feet, and knee joints
.
When patients cannot be followed up regularly, treatment interruption, disease recurrence or aggravation is prone to occur, which greatly affects the long-term prognosis of disease treatment
The approval of the 11mg sustained-release formulation of Pfizer tofatib provides a new treatment option for patients with rheumatoid arthritis.
Reference materials:
[1] Pfizer's innovative rheumatoid arthritis drug tofacitib citrate sustained-release tablets was approved in China.
