Amgen Canada Receives Approval of Marketing Authorization Transfer of OTEZLA® for the Treatment of Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

Nouvelles fournies par

Amgen Canada

12 févr, 2020, 07:00 ET

Addition of OTEZLA Strengthens Amgen's Long-Standing Expertise in Inflammation

MISSISSAUGA, ON, Feb. 12, 2020 /CNW/ - Today, Amgen Canada Inc. ("Amgen Canada") announced Health Canada's approval of the Marketing Authorization transfer of OTEZLA® (apremilast) from Celgene Corporation to Amgen Canada. This transfer is in line with Amgen Inc.'s previously announced acquisition of the worldwide rights to OTEZLA completed in November 2019.

OTEZLA is approved in Canada for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and (alone or in combination with methotrexate) for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response, intolerance, or contraindication to a prior disease-modifying anti-rheumatic drug (DMARD).i

"We are pleased that Health Canada has granted approval for Amgen to market OTEZLA in Canada and we are proud to offer this treatment option to those who need it most, including those living with debilitating, inflammatory conditions," says Brian Heath, vice president and general manager at Amgen Canada. "OTEZLA represents a unique opportunity to build on our long-standing commitment in psoriasis and inflammation and enhances our ability to support both patients and their physicians."

The acquisition of OTZELA complements Amgen Canada's existing portfolio of innovative biologics and biosimilar products and is a strong strategic fit with Amgen Canada's long-standing expertise in moderate-to-severe plaque psoriasis and active psoriatic arthritis.

OTEZLA is approved in more than 50 markets outside Canada including the U.S., the European Union and Japan.

About Psoriasis

Psoriasis is a lifelong condition of the immune system. The exact cause is unknown; however, researchers think that family history, environment, and the immune system can all play a role in psoriasis.ii Psoriasis affects and estimated 1 million Canadiansiii and 125 million people worldwide.iv

Plaque psoriasis is the most common form of the condition and it affects approximately 80 - 90 per cent of patients.v The severity of psoriasis is based on how it affects an individual and how much of their body is covered. Approximately 1 in 5 people with psoriasis have moderate to severe plaque psoriasis.ii

Other types of psoriasis can affect different areas of the body and appear in a variety of forms. Psoriatic arthritis includes a combination of skin and joint symptoms. Up to 30 per cent of people with psoriasis may actually have or develop psoriatic arthritis.vi

About OTEZLA® (apremilast)I

OTEZLA belongs to a class of drugs called phosphodiesterase 4 (PDE4) inhibitors. It contains the active ingredient apremilast which works by reducing the activity of PDE4. This results in less inflammation in the skin and joints.OTEZLA is available in Canada in 10 mg, 20 mg and 30 mg tablets.

Important Safety Informationi

OTEZLA (apremilast) is contraindicated in:

  • Patients who are allergic to apremilast or to any non-medicinal ingredient in the formulation.
  • Pregnancy
  • Women who are breastfeeding.

OTEZLA is not approved for use in combination with any other medicines taken by mouth used to treat psoriasis, biological therapies (such as TNF antagonists and anti-IL-12/23 p40 antibodies) or with phototherapy (light therapy using UV light).

OTEZLA tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take OTEZLA.

In the Phase 3 psoriasis studies, the most common adverse reactions (≥ 5%) were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.

In the Phase 3 psoriatic arthritis studies, diarrhea, nausea, and headache were the most commonly reported (≥ 5%) adverse drug reactions. 

More information on Adverse Reactions may be found in the OTEZLA Product Monograph.

About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.

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SOURCE Amgen Canada

Natasha Bond, Amgen Canada, Ph: 905-285-3007, [email protected]; Marlo Taylor, Ph: 647-233-7636, [email protected]

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