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Amgen Files for Avastin Biosimilar; Repatha Data Positive

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Amgen Inc. (AMGN - Free Report) , along with its partner Allergan plc. (AGN - Free Report) , announced the submission of a Biologics License Application (BLA) to the FDA for its biosimilar version of Roche Holding AG’s (RHHBY - Free Report) Avastin (bevacizumab), ABP 215.

ABP 215 is the most advanced oncology biosimilar in Amgen’s pipeline. The company has a total of nine biosimilar candidates in its portfolio, of which Amjevita, a biosimilar version of AbbVie Inc.’s (ABBV - Free Report) Humira was approved by the FDA this September. The ones under development include biosimilar versions of Roche’s Rituxan, Eli Lilly’s Erbitux, and Johnson and Johnson/Merck’s Remicade. Amgen has also tied up with Daiichi Sankyo for the commercialization of nine biosimilars in Japan.

Note that Amgen has a collaboration agreement with Allergan for the worldwide development and commercialization of the former’s oncology antibody biosimilar medicines.

In a separate press release, Amgen announced that it has presented detailed results of the GLAGOV trial at the American Heart Association (AHA) meeting, which were simultaneously published in the Journal of the American Medical Association.

GLAGOV is a multicenter, double-blinded, randomized, placebo-controlled phase III study, which evaluated the effect of Repatha, a PCSK9 inhibitor, on patients with coronary artery disease (CAD) who were already treated with optimized statin therapy, as measured by intravascular ultrasound imaging (IVUS). Top-line results of the study were announced in September.

The phase III study (n=968), in which patients were given either monthly Repatha 420 mg or placebo subcutaneous injections, showed that Repatha modifies the underlying process of atherosclerosis, a major cause of cardiovascular disease.

The study met the primary as well as the secondary endpoint. The primary endpoint was change in percentage of atheroma volume (PAV) from baseline to week 78 as measured by IVUS.

The study results demonstrated that adding Repatha to optimized statin therapy resulted in statistically significant regression of atherosclerosis in patients with CAD. Nearly two-thirds of patients on Repatha experienced a reduction in plaque burden.

Patients in the Repatha arm experienced a 0.95% decrease in PAV from baseline, compared with an increase of 0.05% from baseline in patients receiving optimized statin therapy plus placebo. Moreover, patients in the Repatha arm experienced a mean decrease in normalized total atheroma volume (TAV), a measure of plaque volume, compared to placebo.

We note that Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet.

Repatha holds the potential to treat patients who are unable to maintain acceptable levels of LDL cholesterol. A phase III cardiovascular outcomes study (FOURIER) on Repatha is currently ongoing with top-line data expected in the first quarter of 2017.




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