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AstraZeneca's Fasenra Gets Orphan Drug Status for New Disease

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AstraZeneca plc’s (AZN - Free Report) respiratory biologic Fasenra was granted orphan drug designation (ODD) by the FDA for a new indication — eosinophilic oesophagitis (EoE) — an allergic inflammatory disease of the oesophagus.  

Currently, there are no FDA approved treatments for EoE in which the accumulation of eosinophils, a type of white blood cell in the esophageal lining tissue, results in patients experiencing several debilitating symptoms including severe pain and difficulty in swallowing food.

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.

Shares of AstraZeneca have rallied 18.1% this year so far against the industry’s decrease of 2.1%.



Fasenra is AstraZeneca’s first respiratory biologic and is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the United States, Europe, Japan and other countries. GlaxoSmithKline’s (GSK - Free Report) Nucala and Teva Pharmaceutical Industries' (TEVA - Free Report) Cinqair are presently marketed for the same indication. Fasenra generated sales of $296 million in the first half of 2019.

In another press release, AstraZeneca announced that a phase III study, evaluating its fixed dose triple combination inhaler Breztri Aerosphere (PT010) in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD) met the primary endpoint.

Breztri Aerosphere is a combination of budesonide, an inhaled corticosteroid (ICS), glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-agonists (LABA) therapy. Breztri Aerosphere can be delivered using AstraZeneca’s Aerosphere Delivery Technology.

In the study, Breztri Aerosphere showed a statistically-significant reduction in the rate of moderate or severe exacerbations — the primary endpoint — at both standard and low budesonide doses compared with AstraZeneca’s own dual-combination therapies — Bevespi and PT009 in the abovementioned COPD patients who have had a history of exacerbation(s) in the previous year.

AstraZeneca stressed that this is the first time that a fixed-dose triple combo inhaler has shown benefit at two ICS doses, which means a doctor gets the flexibility to  select the optimal dose for his patient.

Breztri Aerosphere was approved in Japan in June for the treatment of COPD. Japan marks the first global regulatory approval for Breztri Aerosphere while the candidate is under review in the United States and EU. The regulatory filings seeking approval were based on data from the KRONOS study on Breztri Aerosphere, which compared it to dual combination therapies — Bevespi Aerosphere, Symbicort Turbuhaler and PT009.

Both ETHOS and KRONOS are part of the ATHENA clinical trial program for Breztri Aerosphere, being conducted on more than 15,500 patients globally

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 Novartis (NVS - Free Report) , carrying a Zacks Rank #2 (Buy). Novartis’ earnings estimates for 2019 have gone up 1.8% while that for 2020 have increased 0.4% over the past 30 days. Novartis stock has returned 4.2% so far in 2019.

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