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Amgen (AMGN) Kyprolis Gets FDA Nod for Use With Darzalex Faspro

·3-min read

Amgen Inc. AMGN announced that the FDA has granted approval to its multiple myeloma drug, Kyprolis, for use in combination with J&J’s JNJ Darzalex Faspro (daratumumab and hyaluronidase-fihj).

Darzalex Faspro is the subcutaneous formulation of J&J’s blockbuster multiple myeloma drug, Darzalex (daratumumab).

The latest approval is for Kyprolis in combination with Darzalex Faspro and dexamethasone for the treatment of relapsed/refractory multiple myeloma in adult patients, having received one to three lines of therapy.

Per the company, the FDA approval of Kyprolis in combination with subcutaneous treatment regimen provides increased flexibility and convenience to the given patient population.

Amgen is planning to submit marketing application for Kyprolis to address the given indication across the world.

Please note that Kyprolis is already approved for use in combination with Darzalex plus dexamethasone as well as Bristol-Myers’ BMY Revlimid (lenalidomide) for the treatment relapsed or refractory multiple myeloma in patientswho have received one to three lines of therapy.

The Celgene acquisition in 2019 added multiple myeloma drug, Revlimid, to Bristol-Myers’ portfolio.

The expansion of the Kyprolis U.S. prescribing information to include Darzalex Faspro plus dexamethasone was based data form the multicenter,open-label phase II PLEIADES study that evaluated the clinical benefit of Darzalex Faspro given in combination with four standard-of-care treatment regimens for treating patients with multiple myeloma.

We note that Kyprolis is one of Amgen’s key revenue drivers. In the first nine months of 2021, Kyprolis recorded sales of $824 million, up 4% year over year, driven by higher unit demand.

Shares of Amgen have declined 12.7% so far this year compared with the industry’s decrease 16.1%.

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In a separate press release, Amgen announced positive top-line data from the placebo-controlled, phase III DISCREET study that evaluated the efficacy of its blockbuster drug, Otezla (apremilast), in adults with moderate-to-severe genital psoriasis and moderate-to-severe plaque psoriasis.

Data from the same showed that treatment with Otezla (30 mg) orally, twice-daily led to a clinically meaningful and statistically significant improvement versus placebo at week 16 – the primary endpoint of measures of genital psoriasis.

Otezla is approved in the United States for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis as well as adult patients with oral ulcers associated with Behçet's disease.

Amgen gained rights to Otezla from Celgene (now part of Bristol-Myers) in 2019. The drug generated sales worth $1.6 billion in the first nine months of 2021, reflecting an increase of 3% year over year. A regulatory application seeking approval of Otezla for mild-to-moderate plaque psoriasis is under review in the United States, with a decision expected shortly. Potential label expansion into additional indications should drive sales in future quarters.

Zacks Rank & Stocks to Consider

Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech is Sarepta Therapeutics, Inc. SRPT which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Sarepta Therapeutics’ loss per share estimates have narrowed 31.3% for 2021 and 26% for 2022, over the past 60 days.

Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions.


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