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Alexion's GVHD Candidate Gets Orphan Drug Status in the EU
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Alexion Pharmaceuticals, Inc. announced that the European Commission has granted orphan drug designation to ALXN1007 for the treatment of graft-versus-host disease (GVHD).
We note that ALXN1007 is an anti-inflammatory monoclonal antibody targeting complement protein C5a, currently in a phase II study in patients with newly diagnosed acute GVHD of the lower gastrointestinal tract (GI-GVHD).
The European Commission usually grants orphan medicinal product status in order to provide incentives to candidates that are being developed to treat, prevent or diagnose diseases or conditions affecting no more than 5 in 10,000 people in the region. In addition to providing Alexion with certain benefits and incentives, this status will allow ALXN1007 to enjoy a period of market exclusivity in the EU, if approved, for the treatment of acute GI-GVHD.
Per the company’s press release, GI-GVHD affects roughly 10% of patients who receive an allogeneic hematopoietic stem cell transplant or bone marrow transplant. Patients with severe, acute GI-GVHD have a 30–40% mortality rate within the first six months post transplant.
Considering that there are currently limited treatment options for GI-GVHD, there exists significant unmet need for treatments targeting this severe and life-threatening rare autoimmune disease. If successfully developed and subsequently approved, ALXN1007 could improve response rates in patients suffering from this disorder.
Alexion’s progress with its pipeline candidates has been impressive. Apart from ALXN1007, the company has several other candidates in its pipeline targeting severe and life-threatening rare disorders. These include ALXN1101 (phase II/III – molybdenum cofactor deficiency type A) and ALXN1210 (phase II – paroxysmal nocturnal hemoglobinuria) among others.
Alexion is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
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Alexion's GVHD Candidate Gets Orphan Drug Status in the EU
Alexion Pharmaceuticals, Inc. announced that the European Commission has granted orphan drug designation to ALXN1007 for the treatment of graft-versus-host disease (GVHD).
We note that ALXN1007 is an anti-inflammatory monoclonal antibody targeting complement protein C5a, currently in a phase II study in patients with newly diagnosed acute GVHD of the lower gastrointestinal tract (GI-GVHD).
The European Commission usually grants orphan medicinal product status in order to provide incentives to candidates that are being developed to treat, prevent or diagnose diseases or conditions affecting no more than 5 in 10,000 people in the region. In addition to providing Alexion with certain benefits and incentives, this status will allow ALXN1007 to enjoy a period of market exclusivity in the EU, if approved, for the treatment of acute GI-GVHD.
Per the company’s press release, GI-GVHD affects roughly 10% of patients who receive an allogeneic hematopoietic stem cell transplant or bone marrow transplant. Patients with severe, acute GI-GVHD have a 30–40% mortality rate within the first six months post transplant.
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Considering that there are currently limited treatment options for GI-GVHD, there exists significant unmet need for treatments targeting this severe and life-threatening rare autoimmune disease. If successfully developed and subsequently approved, ALXN1007 could improve response rates in patients suffering from this disorder.
Alexion’s progress with its pipeline candidates has been impressive. Apart from ALXN1007, the company has several other candidates in its pipeline targeting severe and life-threatening rare disorders. These include ALXN1101 (phase II/III – molybdenum cofactor deficiency type A) and ALXN1210 (phase II – paroxysmal nocturnal hemoglobinuria) among others.
Alexion is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>