New base heavy oral drug Otezla approved by British NICE for treatment of severe plaque psoriasis

October 24, 2016 Source: Bio Valley

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US biotechnology giant Celgene's heavy oral anti-inflammatory drug Otezla (apremilast) has recently received good news in the UK. The National Institute for Health and Clinical Excellence (NICE) publishes a final guide to support the use of Otezla in the UK National Health Service (NHS) for unsuitable or acceptable systemic therapies (including cyclosporine, methotrexate, PUVA) [Psoralen UV therapy]) Treatment of severe plaque psoriasis in adult patients with plaque psoriasis. It is estimated that approximately 8,000 patients in the UK are eligible for Otezla treatment. Previously, NICE had refused to approve Otezla in June 2015 at a price that was too expensive and cost-effective.

Psoriasis is an inflammatory disease of the skin and it is estimated that there are approximately 960,000 adult patients in the UK. Although there are currently some effective treatment options available to treat the disease. But there is evidence that a significant proportion of patients are in desperate need of new treatment options.

In the United States and the European Union, Otezla was approved for active psoriatic arthritis (PsA) and moderate to severe plaque psoriasis indications in 2014 and 2015, respectively.

Otezla is the first oral, selective phosphodiesterase 4 (PDE4) inhibitor, the first oral drug approved for psoriasis in the past 20 years, and approved for the past 15 years. The first oral medication for psoriatic arthritis. In relevant clinical trials, Otezla has been shown to achieve clinically significant and lasting improvement in the patient's condition, which will provide a valuable therapeutic option for a wide range of psoriasis patient populations, including previously used biologics. Or a population of patients with conventional systemic medications.

Currently, despite competition from injectable drug tumor necrosis factor (TNF) inhibitors, especially the world's best-selling drug Humira (Xiu Meile, Abbott products, 2013 sales of 10.6 billion US dollars) and Entrel (En Lee, Pfizer/Anjin products, 2013 sales of 8.3 billion US dollars), but Otezla has its unique advantages: (1) clinical drugs do not require routine laboratory monitoring, (2) is an oral drug, compared to the market Injecting drugs will provide an important treatment option for patients and doctors. The industry expects that Otezla's sales peak will exceed $2 billion.

Psoriasis is a chronic inflammatory disease of the skin caused by an uncontrolled immune response. The total number of European patients is about 14 million, and the total number of patients worldwide is more than 125 million. Plaque psoriasis is the most common form of disease, accounting for approximately 80% of cases of psoriasis. About 30% of patients with psoriasis may develop psoriatic arthritis (PsA).

Otezla (apremilast) is an oral small molecule phosphodiesterase (PDE4) inhibitor that regulates the network of pro-inflammatory and anti-inflammatory mediators in cells. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE that is the major PDE in inflammatory cells. PDE4 inhibition can increase intracellular cAMP levels, and down-regulate inflammatory responses by regulating the expression of TNF-α, IL-23 and other inflammatory cytokines. Elevated cAMP also increases anti-inflammatory cytokines such as IL-10.

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