Drug manufacturer Johnson & Johnson is upbeat as the US drug authorities have given a nod to its blockbuster psoriasis drug Stelara, which was to treat adolescent patients aged 12 and above with moderate to severe cases of the skin condition.
SteIara was already approved to treat adolescents with a serious condition such as a chronic, autoimmune inflammatory disorder which causes raised, red patches with a silvery white form of dead skin cells or scale. The condition is described severely painful and itchy. Now the drug has been approved for its expanded use for adolescents of 12 years and above.
The approval is based on data from a Phase 3 study on patients aged 12 years or older. At least two-thirds of patients receiving STELARA were responders at the week 12 primary endpoint after just two doses at weeks 0 and 4, defined by achieving a Physician's Global Assessment (PGA) score of 0 or 1 (cleared or minimal psoriasis).
"Psoriasis is a highly visible disease, and it is essential that these younger patients and their caregivers have options that can effectively reduce the difficult-to-conceal and often misunderstood plaques," said Michael Siegel, Senior Vice President of Research and Clinical Affairs for the National Psoriasis Foundation. "It is encouraging to have new treatment options where few exist for adolescents living with psoriasis during such formative times in their lives."
The drug Stelara is also approved to treat adults with the related psoriatic arthritis and for moderate to severe Crohn's disease. About one-third of people who develop plaque psoriasis do so before 20 years of age.
Psoriasis can affect many aspects of everyday life and the visible plaques, itching and discomfort can take a particular toll on adolescents," said Andrew Greenspan, Vice President of Medical Affairs at Janssen Biotech, a pharma research arm of Johnson & Johnson. "With today's approval, STELARA has the potential to make a meaningful difference in the lives of these young adults."
However, Stelara is a prescription medicine that affects the immune system and it can increase the chance of having serious side effects including. With lowered immunity, it can increase the risk of infections. While taking Stelara, some people have developed serious infections, requiring hospitalization, said a statement of caution from the company. Stelara also leads to tuberculosis (TB) and other infections caused by bacteria, fungi, or viruses, said the note suggesting patients
While taking Stelara, some people have developed serious infections, requiring hospitalization, said a statement of caution from the company. Stelara also leads to tuberculosis (TB) and other infections caused by bacteria, fungi, or viruses, said the note suggesting patients to see their doctor for regular check-ups.
What is Psoriasis?
Psoriasis is a chronic, autoimmune inflammatory disorder that produces excessive skin cells. The resultant psoriasis plaque affects 80 to 90 percent of psoriasis patients. The plaque psoriasis is characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain.
Nearly 80 percent of the patients have mild to moderate disease, while 20 percent have moderate to severe plaque psoriasis. The scalp and face are the most affected areas in adolescents, which leads to emotional and social complications among them.
Plaque psoriasis was one of the widely known diseases that most people are afflicted with. This disease appears as raised, red patches covered with a silvery white formed of dead skin cells. These itchy plaques mostly appear on the scalp, knees, elbows and lower back parts.
Nearly 7.5 million people in the US are affected by psoriasis. "Psoriasis is a highly visible disease, and it is essential that these younger patients and their caregivers have options that can effectively reduce the difficult-to conceal and often misunderstood plaques," said Michael Siegel of the National Psoriasis Foundation.
Stelara was one of the J&J's most approved pharmaceutical products. The sales of J&J are expected to reach US$3.7 billion in 2017. However, with the expanded use of its products, its sales are expected to reach $5 billion by 2021, said a Reuters' update.