Mimpara® (Cinacalcet) Receives Positive CHMP Opinion for Extension of Marketing Authorisation in the European Union

CHMP Opinion Based on Positive Benefit/Risk Assessment in Patients

with Hypercalcemia Due to Primary Hyperparathyroidism and Where

Parathyroidectomy is Not Clinically Appropriate or is Contraindicated
Amgen (Europe) GmbH today announced that the European Committee for

Medicinal Products for Human Use (CHMP) has issued a positive opinion

recommending the extension of the marketing authorization for Mimpara® (cinacalcet) in the European Union (EU) for the reduction of

hypercalcemia in patients with primary hyperparathyroidism (PHPT) for

whom parathyroidectomy would be indicated on the basis of serum calcium

levels (as defined by relevant treatment guidelines), but in whom

parathyroidectomy is not clinically appropriate or is contraindicated.
"As Amgen is committed to providing treatment

options for grievous illnesses where no other treatment options are

available, we are pleased with the CHMP´s

decision to grant Mimpara with a positive opinion. Patients with PHPT

and hypercalcemia, where surgery is not an option, may now benefit from

this new treatment," said Willard Dere, M.D.

senior vice president and chief medical officer, Amgen International. "The

expected new indication is a positive demonstration of Mimpara´s

favorable efficacy and safety profile in these patients."
The CHMP positive opinion for Mimpara is based on a positive

benefit/risk assessment in a patient population that currently has no

other long-term treatment options available to them. As part of the CHMP

review, Amgen´s clinical efficacy and safety

Mimpara data from patients with hypercalcemia due to PHPT in whom

surgery was not a treatment option were evaluated. Following the review

the CHMP concluded that Mimpara fulfills an unmet medical need for this

patient population with uncontrolled hypercalcemia.
About PHPT
PHPT is an endocrine disorder caused by the enlargement of one or more

of the four parathyroid glands and resulting in the release of excess

parathyroid hormone (PTH). PTH regulates the amount of calcium and

phosphorus in the body and plays an important role in several body

systems including the skeletal, gastrointestinal, renal, muscular, and

central nervous systems.
The majority of patients with PHPT requiring an intervention are treated

surgically by parathyroidectomy, however this is not a suitable

treatment option for a small proportion of patients.
About Mimpara
Mimpara® (cinacalcet) (also known as Sensipar® in the United States, Australia and Canada) is a calcimimetic agent that

is approved for the treatment of secondary hyperparathyroidism (SHPT) in

patients with chronic kidney disease receiving dialysis.
Calcimimetics amplify the action of calcium on the calcium-sensing

receptors on the parathyroid gland, thereby decreasing the secretion of

PTH. Mimpara is the first and only calcimimetic agent approved for use

in dialysis patients to specifically bind to and directly modulate the

calcium-sensing receptor on the surface of the chief cell of the

parathyroid gland while simultaneously lowering blood calcium and

phosphorus levels. In dialysis patients, Mimpara significantly reduces

PTH levels while simultaneously lowering blood calcium and phosphorus

levels. Mimpara binds to the parathyroid gland´s

calcium-sensing receptors, making them more sensitive to calcium, which

causes the gland to reduce its release of PTH.
The threshold for seizures may be lowered by reductions in calcium

levels and, infrequently, seizures have been reported with use of

Mimpara. The most commonly reported side effects are nausea and

vomiting. In post-marketing safety surveillance, isolated, idiosyncratic

cases of hypotension and/or worsening heart failure have been reported

in patients with impaired cardiac function, in which a causal

relationship to cinacalcet could not be completely excluded and may be

mediated by reductions in serum calcium levels.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human

therapeutics. A biotechnology pioneer since 1980, Amgen was one of the

first companies to realize the new science´s

promise by bringing safe and effective medicines from lab, to

manufacturing plant, to patient. Amgen therapeutics have changed the

practice of medicine, helping millions of people around the world in the

fight against cancer, kidney disease, rheumatoid arthritis, and other

serious illnesses. With a deep and broad pipeline of potential new

medicines, Amgen remains committed to advancing science to dramatically

improve people´s lives. To learn more about

our pioneering science and our vital medicines, visit www.amgen.com.
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