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Astrazeneca's Fasenra Gets Orphan Drug for Autoimmune Disease

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AstraZeneca, plc’s AZN new asthma drug, Fasenra (benralizumab), was granted orphan drug designation by the FDA for the treatment of eosinophilic granulomatosis with polyangiitis (“EGPA”). The company is developing the drug for treating EGPA in a phase II study.

Notably, the orphan drug designation is granted to drugs capable of treating rare diseases that affect less than 200,000 people in the United States. The status makes Fasenra eligible for seven years of marketing exclusivity in the United States if approved for the given indication. The designation also makes the company entitled to certain other benefits including tax credits related to clinical trial expenses and exemption from FDA user fee.

Fasenra is marketed in Europe and the United States as an add-on maintenance treatment in patients with severe eosinophilic asthma. Fasenra is given as a fixed-dose subcutaneous injection via a prefilled syringe, once in every eight weeks, making it the first respiratory biologic medicine to be approved in the United States and the EU with a convenient 8-week maintenance dosing schedule. GlaxoSmithKline’s GSK Nucala and Teva Pharmaceutical Industries' (TEVA - Free Report) Cinqair are presently marketed for the same indication but administered once every four weeks.

AstraZeneca’s shares have risen 15.5% so far this year compared with the industry’s increase of 6.7%.

Eosinophilic granulomatosis with polyangiitis, formerly known as Churg-Strauss Syndrome, is a rare autoimmune disease, which is caused by inflammation of blood vessels and the presence of elevated levels of eosinophils in blood. The disease may lead to damage of multiple organs, including lungs, skin, heart, gastrointestinal tract and nerves.

The company is also developing the drug for treating severe nasal polyposis in a late-stage study.

Fasenra’s sales have done well so far in 2018 on the back of strong demand in both the United States and Europe. Successful label expansion of the drug in additional indications is likely to drive sales further.

However, in May, AstraZeneca announced that Fasenra has failed to meet primary endpoint of reduction in exacerbations of statistical significance compared to placebo in the phase III study, GALATHEA. The study was evaluating Fasenra as an add-on to dual or triple inhaled therapy in patients with moderate-to-very severe chronic obstructive pulmonary disease.

Zacks Rank

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

A better-ranked large-cap pharma stock is Merck & Co., Inc. MRK with a Zacks Rank #2 (Buy). The company’s earnings estimates have increased from $4.27 to $4.34 for 2018 and from $4.63 to $4.71 for 2019 over the past 60 days.

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