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Amgen Gets EU Nod to Expand Hyperparathyroidism Drug Label

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Amgen, Inc. (AMGN - Free Report) announced that the European Commission has approved the marketing application for a pediatric formulation (granules in capsule for opening) of Mimpara for the treatment of secondary hyperparathyroidism (sHPT).

With this approval, the drug’s label has been expanded to include use in children aged three years and above with end-stage renal disease (ESRD) on maintenance dialysis therapy where standard of care therapy cannot adequately control secondary HPT.

We remind investors that in June, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had rendered a positive opinion, recommending marketing approval of Mimpara for the expanded label.

Amgen’s shares have rallied 17.8% this year so far, better than the industry’s 12.3% registered increase.

The approval was based on data from studies assessing the use of Mimpara in pediatric secondary HPT patients, conducted by Amgen since 2007.

Mimpara is already approved and marketed in the EU as an oral therapy for treating secondary HPT in adult patients with ESRD on maintenance dialysis therapy and for mitigating hypercalcemia in adult patients with parathyroid carcinoma. In the United States, the drug is marketed by the trade name Sensipar.

Sensipar/Mimpara generated sales of $427 million in the second quarter of 2017, up 10% year over year. The label expansion is expected to boost international sales of the drug.

We remind investors that Sensipar is set to face generic competition in March next year. Many companies are seeking to market the drug’s generic versions regarding formulation patent.

Secondary hyperparathyroidism is often progressive in patients suffering from chronic kidney disease (CKD). It affects around 88% of CKD patients on hemodialysis. Meanwhile, very few treatment options are available to treat this condition.

Investors must also note that Amgen markets another sHPT medicine, Parsabiv, approved in the United States earlier in February and in the EU, back in November 2016. Parsabiv is approved to treat sHPT in adult patients with CKD on hemodialysis, the first therapy in 12 years to be approved for this condition. The drug has to be administered intravenously thrice a week at the end of a dialysis session.

Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Stocks to Consider

Better-ranked biotech stocks include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , Ligand Pharmaceuticals Incorporated (LGND - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , all with a Zacks Rank #1 (Strong Buy).

Shares of Alexion have increased 13.1% year to date while estimates for both 2017 and 2018 have risen by almost 6% over the past 60 days.

Regeneron’s shares have surged 30.5% this year so far. Estimates have risen 16% for 2017 while that for 2018, have gone up by 6 % over the past 30 days.

Shares of Ligand have risen 24.9% so far this year while estimates for 2017 and 2018 have risen by 10.4% and 2.2%, respectively, over the past 30 days.

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