Zydus Cadila gets USFDA nod for arthritis drug with 180-days exclusivity

INDIA – Drug firm Zydus Cadila has received final approval from the US health regulator to market Tofacitinib extended-release tablets, used to treat rheumatoid arthritis, in the American market.

The company said it has received approval from the US Food and Drug Administration (USFDA) for the drug in 11 mg and 22 mg strengths.

Zydus was the first abbreviated new drug application (ANDA) filer on Tofacitinib extended-release tablets 22 mg and thus holds 180-day exclusivity on this strength, the company said in a statement.

Arthritis, or joint disease, is inflammation of one or more of the joints, such as the knees, knuckles, wrists, or ankles. Arthritis starts as joint inflammation but can progress into joint pain, swelling, and stiffness.

There are more than 100 different types of arthritis that someone can be diagnosed with, but the two most common types are rheumatoid arthritis and osteoarthritis.

WHO reported that at least 14 million people around the world have rheumatoid arthritis in 2021. 60% of people who have arthritis are between the ages of 18 and 64.

In 2020, American CDC reported that the projected prevalence of US adults who will report doctor-diagnosed arthritis, by year: 2020: 63 million; 2025: 67 million and 72 million by 20130.

Even though arthritis can be painful, there are treatments available to help reduce pain, inflammation, and stiffness. A 2010 study found that 42% of people who received a combination of rheumatoid arthritis treatments achieved complete remission within two years of starting treatment.

Data provided by Allied Market Research shows the global rheumatoid arthritis drugs market size was valued at US$57,929 million in 2019, and is projected to reach US$62,935 million by 2027, registering a CAGR of 2.8% from 2020 to 2027.

Rise in prevalence of rheumatoid arthritis, increase in demand for rheumatoid arthritis drugs, expiration of patents & the entry of biosimilar drugs, surge in geriatric population, increase in adoption of conventional DMARDs, and government initiatives toward spread in awareness for rheumatoid arthritis symptoms are the major factors that drive growth of the rheumatoid arthritis drugs market.

According to IQVIA data, Tofacitinib extended-release tablets had annual sales of around US$2,082 million in the US for the year ending June 2021.

Zydus said it would produce the drug at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

The Zydus group now has 321 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in 2003-04, it added.

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