Immunosuppressants

DGAP-News: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Saturday, August 1, 2020 - 1:00am

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Key Points: 
  • The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
  • "The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States," said Herv Hoppenot, Chief Executive Officer, Incyte.
  • "Today's FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy."
  • The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL.

FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Saturday, August 1, 2020 - 12:51am

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Key Points: 
  • The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
  • The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States, said Herv Hoppenot, Chief Executive Officer, Incyte.
  • The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL.
  • The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL.

Genmab Announces European Myeloma Network and Janssen Achieve Positive Topline Results from Phase 3 APOLLO Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Friday, July 31, 2020 - 8:38pm

We are pleased with these positive results for daratumumab, administered as a subcutaneous formulation, in combination with pomalidomide and dexamethasone.

Key Points: 
  • We are pleased with these positive results for daratumumab, administered as a subcutaneous formulation, in combination with pomalidomide and dexamethasone.
  • This Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI.
  • In the original design of the study, patients in the daratumumab plus Pd arm were treated with the IV formulation of daratumumab.
  • A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings.

U.S. Food and Drug Administration Approves STELARA® (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

Thursday, July 30, 2020 - 9:30pm

"While STELARA is currently available for adults and adolescents 12 years and older, children with plaque psoriasis have had more limited treatment options."

Key Points: 
  • "While STELARA is currently available for adults and adolescents 12 years and older, children with plaque psoriasis have had more limited treatment options."
  • "The approval of new treatment options is an exciting step forward to address the unmet needs of children living with psoriasis."
  • Janssen CarePath offers a comprehensive support program that helps patients get started on STELARA and stay on track.
  • Plaque psoriasis (PsO) is the most common form of psoriasis in adults and children.

Takeda's Entyvio and Janssen's Stelara Share of Inflammatory Bowel Disease Biologic-Naive Patients Continues to Increase as This Patient Group Expands Their Involvement in the Decision-Making Process

Thursday, July 30, 2020 - 12:50pm

AMOAs, such as Takeda's Entyvio, Janssen's Stelara, and Pfizer's Xeljanz, collectively represent one-third of the currently treated, first-time biologic/small molecule IBD patients.

Key Points: 
  • AMOAs, such as Takeda's Entyvio, Janssen's Stelara, and Pfizer's Xeljanz, collectively represent one-third of the currently treated, first-time biologic/small molecule IBD patients.
  • While the Spherix study focuses on biologic-nave patients, the survey also asks about potential next steps for these patients.
  • In almost half of the new patients receiving Stelara, if Stelara was not available, Entyvio would have been prescribed instead.
  • Unlike Stelara, where first-line use was relatively flat, Entyvio's share of Crohn's disease patients versus last year increased as well.

Scipher Medicine™ Announces Publication of Clinical Study Validating PrismRA®, a Blood Test Predicting Non-Response to TNF Inhibitor Therapies in Patients with Rheumatoid Arthritis

Tuesday, July 28, 2020 - 1:00pm

The publication titled Clinical validation of a blood-based predictive test for stratification of response to tumor necrosis factor inhibitor therapies in rheumatoid arthritis patients was published in Network and Systems Medicine .

Key Points: 
  • The publication titled Clinical validation of a blood-based predictive test for stratification of response to tumor necrosis factor inhibitor therapies in rheumatoid arthritis patients was published in Network and Systems Medicine .
  • PrismRA uses whole blood gene expression data to identify if a patients molecular disease biology is suited to TNFi therapy.
  • About 90% of patients with rheumatoid arthritis are prescribed TNFi therapy after failing disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate.
  • However, a majority of patients fail to achieve a clinically meaningful change, said Dr. Slava Akmaev, Chief Technology Officer of Scipher Medicine.

Aurinia Closes US$200 Million Public Offering of Common Shares

Monday, July 27, 2020 - 3:15pm

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the closing of its previously announced underwritten public offering of 13,333,334 common shares (the Offering).

Key Points: 
  • Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the closing of its previously announced underwritten public offering of 13,333,334 common shares (the Offering).
  • The shares were sold at a public offering price of US$15.00 per share.
  • The gross offering proceeds to the Company from this Offering are approximately US$200 million, before deducting underwriting discounts and commissions and other offering expenses.
  • Cantor acted as lead manager and Oppenheimer & Co. and H.C. Wainwright & Co. acted as co-managers for the Offering.

European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima® SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis

Monday, July 27, 2020 - 12:38pm

Celltrion anticipates receiving approval of Remsima SC in 97 countries, including 31 countries in Europe.

Key Points: 
  • Celltrion anticipates receiving approval of Remsima SC in 97 countries, including 31 countries in Europe.
  • All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards.
  • A 120 mg fixed dose of Remsima SC has been granted marketing authorisation in the EU, in adults regardless of body weight, in all previously approved indications for the IV formulation.
  • CT-P13 is developed and manufactured by Celltrion, Inc. and was the worlds first monoclonal antibody biosimilar approved by the European Commission (EC).

GILEAD  AND  GALAPAGOS  ANNOUNCE  POSITIVE  EUROPEAN  CHMP  OPINION  FOR  JYSELECA®  (FILGOTINIB)  FOR  THE  TREATMENT  OF  ADULTS  WITH  MODERATE  TO  SEVERE  RHEUMATOID  ARTHRITIS

Friday, July 24, 2020 - 1:14pm

The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe.

Key Points: 
  • The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe.
  • The CHMP positive opinion is supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs, which included 4,544 RA patient-years of experience with filgotinib.
  • The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to authorize medicines in the 27 countries of the European Union, Norway, Iceland, Liechtenstein and UK.
  • Jyseleca, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

Target Enrollment Reached in MIRROR Randomized Controlled Trial Evaluating KRYSTEXXA® (pegloticase injection) Co-Prescribed with Methotrexate as an Immunomodulator to Enhance Response Rates for People Living with Uncontrolled Gout

Wednesday, July 22, 2020 - 1:00pm

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the Company has reached target patient enrollment for its Methotrexate to Increase Response Rates in Patients With Uncontrolled GOut Receiving KRYSTEXXA [(MIRROR) randomized controlled trial (RCT)].

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the Company has reached target patient enrollment for its Methotrexate to Increase Response Rates in Patients With Uncontrolled GOut Receiving KRYSTEXXA [(MIRROR) randomized controlled trial (RCT)].
  • MIRROR RCT has reached its target enrollment of 135 patients; those currently in the screening process, if eligible once the screening is complete, will randomize.
  • Patients are randomized to receive methotrexate or placebo for four weeks and then treatment with KRYSTEXXA and methotrexate or KRYSTEXXA and placebo for 52 weeks.
  • Albert J, Hosey T, LaMoreaux B. Pegloticase response rate in uncontrolled gout patients co-treated with methotrexate: experience in a community rheumatology practice.