We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Incyte (INCY) Jakafi Wins FDA Approval for Chronic GVHD
Read MoreHide Full Article
Incyte (INCY - Free Report) recently announced that the FDA has approved a label expansion of its JAK1/JAK2 inhibitor, Jakafi (ruxolitinib). The drug can now be used for the treatment of chronic graft-versus-host disease (GVHD) after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
The FDA approval was based on the phase III REACH3 study that compared Jakafi to the best available therapy (BAT) for the treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation. Data showed that the primary endpoint of the overall response rate (ORR) at week 24 was 49.7% for Jakafi compared with 25.6% for BAT.
Jakafi is already approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults. It is also approved for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.
GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient’s organs. Acute GVHD generally occurs within 100 days of transplant. Chronic GVHD occurs more than 100 days after transplant.
Incyte has a collaboration agreement with Novartis (NVS - Free Report) for Jakafi.
The approval of additional indications should generate incremental revenues.
It has been raining good news for Incyte this week after a few setbacks earlier in the year. On Sep 21, the FDA approved the cream formulation of ruxolitinib for the treatment of mild to moderate atopic dermatitis (AD). Ruxolitinib cream has been approved under the brand name Opzelura for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older.
However, shares were down 8% on Sep 22 despite back-to-back approvals. This is perhaps due to the FDA’s recent update on warnings about increased risks of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions. While JAK inhibitors, Jakafi and Bristol Myers' (BMY - Free Report) Inrebic (fedratinib), are not indicated for the treatment of arthritis and other inflammatory conditions and are not part of the updates being required for prescribing information for other inhibitors, there is a cloud of uncertainty regarding the same and hence the decline.
Shares of the company have lost 20% in the year so far compared with the industry’s 0.7% decline.
Image Source: Zacks Investment Research
Incyte’s lead drug Jakafi sales recorded growth in the second quarter after a soft first quarter. The uptake of Pemazyre is also gaining traction. The company’s efforts to diversify its revenue base are encouraging as well and approval of additional drugs will boost revenues.
Last month, Incyte and partner MorphoSys AG obtained the European Commission’s approval for tafasitamab under the brand name Minjuvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Image: Bigstock
Incyte (INCY) Jakafi Wins FDA Approval for Chronic GVHD
Incyte (INCY - Free Report) recently announced that the FDA has approved a label expansion of its JAK1/JAK2 inhibitor, Jakafi (ruxolitinib). The drug can now be used for the treatment of chronic graft-versus-host disease (GVHD) after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
The FDA approval was based on the phase III REACH3 study that compared Jakafi to the best available therapy (BAT) for the treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation. Data showed that the primary endpoint of the overall response rate (ORR) at week 24 was 49.7% for Jakafi compared with 25.6% for BAT.
Jakafi is already approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults. It is also approved for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.
GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient’s organs. Acute GVHD generally occurs within 100 days of transplant. Chronic GVHD occurs more than 100 days after transplant.
Incyte has a collaboration agreement with Novartis (NVS - Free Report) for Jakafi.
The approval of additional indications should generate incremental revenues.
It has been raining good news for Incyte this week after a few setbacks earlier in the year. On Sep 21, the FDA approved the cream formulation of ruxolitinib for the treatment of mild to moderate atopic dermatitis (AD). Ruxolitinib cream has been approved under the brand name Opzelura for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older.
However, shares were down 8% on Sep 22 despite back-to-back approvals. This is perhaps due to the FDA’s recent update on warnings about increased risks of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions. While JAK inhibitors, Jakafi and Bristol Myers' (BMY - Free Report) Inrebic (fedratinib), are not indicated for the treatment of arthritis and other inflammatory conditions and are not part of the updates being required for prescribing information for other inhibitors, there is a cloud of uncertainty regarding the same and hence the decline.
Shares of the company have lost 20% in the year so far compared with the industry’s 0.7% decline.
Image Source: Zacks Investment Research
Incyte’s lead drug Jakafi sales recorded growth in the second quarter after a soft first quarter. The uptake of Pemazyre is also gaining traction. The company’s efforts to diversify its revenue base are encouraging as well and approval of additional drugs will boost revenues.
Last month, Incyte and partner MorphoSys AG obtained the European Commission’s approval for tafasitamab under the brand name Minjuvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Incyte currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.