U.S. markets closed
  • S&P 500

    3,638.35
    +8.70 (+0.24%)
     
  • Dow 30

    29,910.37
    +37.90 (+0.13%)
     
  • Nasdaq

    12,205.85
    +111.44 (+0.92%)
     
  • Russell 2000

    1,855.27
    +10.25 (+0.56%)
     
  • Crude Oil

    45.53
    -0.18 (-0.39%)
     
  • Gold

    1,788.10
    -23.10 (-1.28%)
     
  • Silver

    22.64
    -0.81 (-3.44%)
     
  • EUR/USD

    1.1970
    +0.0057 (+0.48%)
     
  • 10-Yr Bond

    0.8420
    -0.0360 (-4.10%)
     
  • GBP/USD

    1.3314
    -0.0042 (-0.32%)
     
  • USD/JPY

    104.0850
    -0.1650 (-0.16%)
     
  • BTC-USD

    17,760.12
    +574.77 (+3.34%)
     
  • CMC Crypto 200

    333.27
    -4.23 (-1.25%)
     
  • FTSE 100

    6,367.58
    +4.65 (+0.07%)
     
  • Nikkei 225

    26,644.71
    +107.40 (+0.40%)
     

Pfizer's Eczema Drug Eucrisa Gets FDA Approval for Infants

Zacks Equity Research
·3 min read

Pfizer Inc. PFE announced that the FDA has approved a supplemental new drug application (sNDA) for its eczema drug, Eucrisa (crisaborole) ointment, 2%. The sNDA sought label expansion of Eucrisa for the treatment of mild-to-moderate atopic dermatitis (“AD”) or eczema in children aged three months to two years. With this approval, Eucrisa becomes the first and only steroid-free, topical prescription medication for use in infants and toddlers up to age of 24 months.

The approval is based on data from a phase IV study, CrisADe CARE 1, which evaluated Eucrisa in infants aged 3 months to less than 24 months with mild-to-moderate AD. Data from the study showed that the drug was well-tolerated over a four-week regimen and its safety profile was consistent with the previous clinical studies.

Please note that the drug is already approved for eczema in patients aged two years and older in the United States and Canada. The drug is also marketed in Israel and Australia under the brand name Staquis for the given patient population.

We would like to remind investors that Pfizer added Eucrisa to its portfolio with the acquisition of Anacor Pharmaceuticals in June 2016. The company estimates Eucrisa’s peak sales potential to be at least $2 billion.

Per the press release, among all AD cases, a total of 45% begin within the first six months of life and 60% start during the first year. The label expansion of Eucrisa in children aged three months to two years is likely to boost its prospects further.

Shares of Pfizer have declined 24.2% so far this year compared with the industry’s decrease of 23.9%.

Another interesting eczema candidate in Pfizer’s portfolio is its investigational JAK1 inhibitor, abrocitinib. Earlier this month, the company had announced top-line data from a phase III study, which showed that a statistically higher percentage of patients receiving abrocitinib witnessed improvement in clear skin from baseline compared to placebo. An NDA is expected to be filed seeking approval for the candidate in AD patients in the third quarter of 2020.

Notably, many companies are developing medicines to address AD/eczema. A key new entrant in the AD market is Sanofi SNY /Regeneron Pharmaceuticals’ REGN Dupixent. Other key immunology candidates in late-stage development for AD include AbbVie’s Rinvoq and Lilly’s LLY Olumiant.

Pfizer Inc. Price

 

Pfizer Inc. Price
Pfizer Inc. Price

Pfizer Inc. price | Pfizer Inc. Quote

Zacks Rank

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

More Stock News: This Is Bigger than the iPhone!

It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.

Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.

Click here for the 6 trades >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
 
Sanofi (SNY) : Free Stock Analysis Report
 
Pfizer Inc. (PFE) : Free Stock Analysis Report
 
Eli Lilly and Company (LLY) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research