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Amgen Gets FDA Nod to Add ASPIRE Data on Kyprolis Label

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Biotech major Amgen Inc. (AMGN - Free Report) gained FDA approval to include the positive overall survival data in multiple myeloma from the late-stage ASPIRE study in Kyprolis label.

Final data from the phase III ASPIRE study presented in July last year showed that a triple combination regimen of Kyprolis significantly improved overall survival (OS) in patients with relapsed/refractory multiple myeloma.

Overall survival data from the study showed that patients with relapsed or refractory multiple myeloma lived 7.9 months longer when treated with Kyprolis plus Celgene’s (CELG - Free Report) Revlimid (lenalidomide) and dexamethasone (KRd ) compared to those treated with Revlimid and dexamethasone (Rd) (median OS of 48.3 months for KRd versus median OS of 40.4 months for Rd). The data also showed that KRd reduced the risk of death by 21% compared to Rd.

While Kyprolis, a proteasome inhibitor, is already approved for use in combination with Revlimid and dexamethasone for patients with relapsed multiple myeloma, the overall survival data should help drive usage and boost sales.

Amgen’s shares have gained 6.2% so far this year against the 6.8% decrease registered by the industry.

A similar application is also under review in the EU. In April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion recommending inclusion of the OS data from the ASPIRE study in the label of Kyprolis.

In early 2018, Amgen gained FDA approval to include overall survival data from the head-to-head ENDEAVOR study on the label of Kyprolis

With the approval to include OS results from ASPIRE study, Kyprolis label now includes OS data from two phase III studies which should drive sales of the drug in future quarters.

Kyprolis has become a key revenue driver for Amgen. The drug recorded sales of $222 million in the first quarter of 2018, representing growth of 17% year over year, driven by increased demand and a robust uptake from outside U.S. markets.

Kyprolis represents significant commercial potential. Sales are likely to be driven by launch in additional countries, expansion into additional indications and a longer duration of treatment.

Amgen also has a collaboration with J&J (JNJ - Free Report) to study the combination of Kyprolis and J&J’s Darzalex in multiple clinical studies for the treatment of multiple myeloma.

Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked biotech stock is BioMarin Pharmaceutical Inc. (BMRN - Free Report) with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

BioMarin’s earnings per share estimates increased 47.7% for 2018 and 20.0% for 2019 in the last 60 days. The average earnings surprise in the trailing four quarters is 42.4%. The company’s shares have risen 0.7% year to date.

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