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Amgen Inc.

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A supplemental Biologics License Application for a monthly administration single-dosing option was submitted to FDA and has received a Prescription Drug User Fee Act target action date of July 10, 2016.
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Source: press release, 10/28/15. http://www.amgen.com/media/news-releases/2015/10/amgens-third-quarter-20...

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Amgen Submits Application To FDA For New Delivery Option For Monthly Administration Of Repatha™ (Evolocumab)
Would Allow 420 mg Monthly Dose to be Administered as a Single Injection
THOUSAND OAKS, Calif., Sept. 11, 2015 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of an application to the U.S. Food and Drug Administration (FDA) seeking approval of a single-dosing option for the monthly administration of RepathaTM (evolocumab) Injection, allowing the 420 mg monthly dose to be administered as a single injection. Approved by the FDA on Aug. 27, 2015, Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.1

Repatha is approved as an adjunct to diet and maximally tolerated statins in patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.

"We are very excited about the recent approval of Repatha in the U.S. as a new treatment option for patients who are in need of lowering their LDL cholesterol," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "In addition to the SureClick® autoinjector, we are developing this monthly single injection to provide patients with another option to administer Repatha every month. Patients who are in need of lowering their cholesterol levels are often on more than one medication and some may prefer a single-dose option for receiving Repatha once monthly."

Repatha is available as a single-use 140 mg/mL prefilled SureClick autoinjector or prefilled syringe that patients can self-administer at the recommended dose for adults of 140 mg every two weeks or 420 mg once a month. For patients with HoFH, the recommended dose is 420 mg once a month.
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Source: press release, 9/11/15. http://www.amgen.com/media/news-releases/2015/09/amgen-submits-applicati...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Repatha (Evolocumab) (AMG 145)CardiovascularAtherosclerosisPCSK9 inhibitorPCSK9

Mechanism of action: Repatha (Evolocumab) (AMG 145) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood causing bad cholesterol to increase. AMG 145, developed by Amgen scientists, binds to PCSK9 circulating in the blood and prevents PCSK9 from binding to LDL receptors in the liver. Without PCSK9 bound to them, the LDL receptors can take up and remove LDL-C from the blood, recycle and remain available for binding additional LDL-C.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-07-10

Results:

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FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor
Repatha® (evolocumab) Pushtronex™ System Available to U.S. Patients in Early August
THOUSAND OAKS, Calif., July 11, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® (evolocumab) Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option.1 The Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose. Repatha is a human monoclonal antibody that blocks a protein called proprotein convertase subtilisin/kexin type 9 (PCSK9), which inhibits the body's natural system for eliminating "bad" cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.1 Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option.

Repatha(R) (evolocumab) Pushtronex(TM) system (on-body infusor with prefilled cartridge)
"The Pushtronex system exemplifies Amgen's continued innovation and commitment to patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration. The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide."

In the U.S., Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) over age 13, who require additional lowering of LDL-C.1 The effect of Repatha on cardiovascular morbidity and mortality has not been determined.

The new, single-use device was developed in collaboration with West Pharmaceutical Services, based on the SmartDose® technology platform, to provide patients with an additional dosing option for Repatha treatment. The device adheres to the body and patients are hands free during administration. Patients are able to perform moderate physical activities (such as walking, reaching or bending) as the 420 mg of Repatha is delivered subcutaneously.

The U.S. Wholesale Acquisition Cost (WAC) price of Repatha is $14,100 annually, whether it is delivered monthly via Pushtronex system or every two weeks via SureClick® autoinjector. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance. The Pushtronex system will be available to patients in the U.S. in early August.

Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood and is recognized as a major risk factor for cardiovascular disease.2-5 In the U.S., there are approximately 11 million people with ASCVD and/or familial hypercholesterolemia (FH) who have uncontrolled levels of LDL-C over 70 mg/dL, despite treatment with statins or other cholesterol-lowering therapies.6,7 FH is caused by genetic mutations that lead to high levels of LDL-C at an early age.8 It is estimated that one million people in the U.S. have FH, yet less than one percent are diagnosed.9

About Repatha® (evolocumab)
Repatha® (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.1

GLAGOV, the intravascular ultrasound study, is underway to determine the effect of Repatha on coronary atherosclerosis in approximately 950 patients undergoing cardiac catheterization to test the hypothesis of robust LDL-C reduction leading to a reduction or a change in the build-up of plaque in the arteries. Results from the GLAGOV study are expected in the second half of 2016.

The FOURIER outcomes trial is designed to evaluate whether treatment with Repatha in combination with statin therapy, compared to placebo plus statin therapy, reduces the risk of cardiovascular events in patients with high cholesterol and clinically evident cardiovascular disease, and completed patient enrollment in June 2015. Top-line results from the approximately 27,500-patient event-driven FOURIER study are anticipated in first quarter of 2017.

Repatha is approved in 43 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.
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Source: press release, 7/11/16. http://wwwext.amgen.com/media/news-releases/2016/07/fda-approves-first-a...

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