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Roche's Esbriet Gets FDA Breakthrough Tag for New Indication
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Roche Holding AG’s (RHHBY - Free Report) 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 - Free Report) 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.
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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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Roche's Esbriet Gets FDA Breakthrough Tag for New Indication
Roche Holding AG’s (RHHBY - Free Report) 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 - Free Report) 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.
Roche Holding AG Price
Roche Holding AG price | Roche Holding AG Quote
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 - Free Report) and Pfizer Inc. (PFE - Free Report) , 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.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>