Roche's Esbriet Gets FDA Breakthrough Tag for New Indication

Roche Holding AG’s RHHBY member, Genentech, announced that the FDA has granted Breakthrough Therapy designation to Esbriet (pirfenidone) for the treatment of adults with unclassifiable interstitial lung disease (uILD). ILD broadly describes a diverse group of more than 200 types of rare pulmonary diseases. The study represents the first randomized controlled trial to exclusively enroll patients with progressive fibrosing uILD.

FDA’s Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions. The designation also indicates that Esbriet is eligible for accelerated approval and priority review depending upon certain criteria. The designation was granted on the basis of a phase II study, which assessed the efficacy and safety of Esbriet in uILD. The data showed that the drug slowed disease progression and supported its efficacy on a number of lung function parameters, including forced vital capacity (FVC), in people with uILD at 24 weeks.

We remind investors that Esbriet is an oral medicine approved for the treatment of idiopathic pulmonary fibrosis (IPF), which is available in more than 60 countries worldwide. The drug generated sales of CHF1.1 billion in 2019.

Shares of the company have rallied 20.8% in the past year compared with the industry’s 6.3% growth.

A potential approval of Esbriet for the treatment of uILD will further boost sales for the company.

Notably, aTyr Pharma, Inc. LIFE is also developing ATYR1923 for interstitial lung diseases (ILDs) in Japan. aTyr is currently enrolling in a proof-of-concept phase Ib/IIa study evaluating ATYR1923 in patients with pulmonary sarcoidosis. This is a multi-ascending dose, placebo-controlled, first-in-patient study that has been designed to evaluate the safety, tolerability, steroid-sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923.

 

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Zacks Rank and Stocks to Consider

Roche currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the healthcare sector are Novartis AG NVS and Pfizer Inc. PFE, both sporting a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Novartis’ earnings per share estimates have increased from $5.67 to $5.74 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 6.25%, on average.

Pfizer’s earnings per share estimates have increased from $2.67 to $2.80 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 7.46%, on average.

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