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J&J (JNJ) Anaemia Drug Marketing Label Expanded in Europe

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Johnson & Johnson (JNJ - Free Report) announced that the French health authority has granted approval to expand the label of its anaemia drug Eprex to include treatment of symptomatic anaemia in patients with low or intermediate risk myelodysplastic syndromes (MDS) in the mutual recognition procedure (MRP).

This year so far, J&J’s share price is up 8.9%. This compares favorably with the 6.2% increase witnessed by the Zacks classified Large-Cap Pharma industry.

Eprex is an erythreopoiesis stimulating agent (ESA) presently approved to treat certain types of anaemia, including chemotherapy-induced anaemia and anaemia due to chronic kidney disease. However, no ESAs have been approved until now to treat anaemia in patients with MDS.  

Under the MRP procedure, one or several Member States obtains marketing authorizations, when the drug has already been granted authorization by at least one country in the European Community. In this case, the French health authority has acted as the reference Member state within the MRP. Upon conclusion of the extension procedure, the other European Health authorities are required to implement the new indication within 30 days.

The outcome of the MRP thus brings J&J closer to offering a new treatment option to patients with MDS - related anaemia throughout Europe.

The approval was based on positive data from a phase III study EPOANE 3021 along with three registry studies from across Europe.

The drug is marketed by the trade name of Procrit in the U.S. Procrit/Eprex recorded sales of $1.1 billion in 2016, up 3.5% year over year.

Other marketed ESAs include Novartis AG’s (NVS - Free Report) Binocrit (biosimilar version) and Amgen, Inc.’s (AMGN - Free Report) Aranesp.

J&J carries a Zacks Rank #3 (Hold). A better-ranked large-cap pharma stock worth considering is GlaxoSmithKline plc (GSK - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of Glaxo have rallied 9.8% this year so far while estimates for 2017 and 2018 improved 3.8% and 1.8%, respectively, in the past 60 days.

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