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Sanofi (SNY)/Regeneron's Libtayo Gets FDA Nod for 2nd Indication

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Sanofi (SNY - Free Report) , along with partner Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved their skin cancer drug, Libtayo (cemiplimab-rwlc) for a new indication. The drug is now approved for the treatment of advanced basal cell carcinoma (“BCC”) in patients who were previously treated with a hedgehog pathway inhibitor (“HHI”) or for whom an HHI is not appropriate. While the approval for advanced BCC was a full approval, the FDA also granted accelerated approval for patients with metastatic BCC.

The above approval marks the second indication for Libtayo in the United States. Libtayo is presently approved to treat metastatic cutaneous squamous cell carcinoma (“CSCC”) or locally advanced CSCC which are not candidates for curative surgery or curative radiation.

BCC is the most common type of skin cancer in the country. The approval was based on data from an open-label multicenter phase II study which evaluated Libtayo in patients with unresectable locally advanced BCC or metastatic BCC.

The primary efficacy endpoint of the study was confirmed objective response rate while duration of response was a key secondary endpoint, as assessed by an independent central review. Notably, Libtayo is the first treatment to demonstrate a clinical benefit in patients with advanced BCC after HHI therapy in a pivotal study.

Following the FDA nod, Libtayo became the first immunotherapy indicated for treating patients with advanced BCC. The drug is now approved for addressing advanced stages of the two most common skin cancers in the United States. Libtayo is currently under review in Europe for advanced BCC.

Libtayo as monotherapy is also being evaluated to treat patients with first-line locally advanced or metastatic non-small cell lung cancer. The FDA has granted priority review to the sBLA with a target action date of Feb 28, 2021.

Libtayo generated sales worth $348.2 million in 2020 reflecting an increase of 79.6% year over year. Further label expansion of the drug should drive sales in the days ahead.

Please note that Regeneron records net product sales of Libtayo in the United States while Sanofi records net product sales of Libtayo outside the country.

Shares of Sanofi have inched up 0.6% so far this year compared with the industry’s increase of 1%.

price chart for SNY

Meanwhile, shares of Regeneron have risen 1.6% so far this year compared with the industry’s rally of 13.7%.

price chart for REGN

In a separate press release, Sanofi announced that the European Commission has approved its blood thinner Plavix (clopidogrel) in combination with aspirin for treating adults within 24 hours of minor ischemic stroke or moderate-to-high-risk transient ischemic attack.

The EU approval was based on data from two placebo-controlled double-blind phase III studies, which showed that the combination of Plavix plus aspirin initiated within 24 hours is superior to aspirin alone for reducing the risk of subsequent stroke. The combination also had an overall acceptable safety profile.

Zacks Rank & Stocks to Consider

Sanofi currently has a Zacks Rank #4 (Sell) while Regeneron currently has a Zacks Rank #3 (Hold).

Better-ranked stocks in the healthcare sector include AbbVie Inc. (ABBV - Free Report) and Johnson & Johnson (JNJ - Free Report) , both sporting a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AbbVie’s earnings estimates have been revised 2.4% and 2.8% upward for 2021 and 2022, respectively over the past 60 days.

Johnson & Johnson’s earnings estimates have been revised 6.5% and 4.6% upward for 2021 and 2022, respectively over the past 60 days. The stock has increased 5.6% year to date.

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