CHMP Adopts Positive Opinion of Subcutaneous Remsima (But only for RA)

October 1, 2019

Impact: High

  • The CHMP adopted a positive opinion recommending a change in the MAA for Remsima to include a new route of administration, new strength, and new pharmaceutical form:
  • Remsima 120 mg solution for subQ injection using prefilled pens or syringes.
  • It is only authorized in the RA indication.

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FDA Approves Ardelyx Tenapanor (Ibsrela) for IBS-C

September 25, 2019

Impact: High

Ardelyx received FDA approval for tenapanor for the treatment of IBS-C in adults. The approval was based on two phase 3 clinical trials, T3MPO 1 and T3MPO2. The brand name for the drug will be Ibsrela. The label contains a black box warning on the risk of serious dehydration in pediatric patients, which is due to a class effect of NHE3 sodium transport inhibitors.

Ardelyx has decided not to commercialize the drug for IBS-C indication themselves and is awaiting a commercial partner who would also be interested in developing the drug for CIC. The company did not disclose details of ongoing partnership conversations during the call following tenapanor’s approval. Read more

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Pivotal DREAMM-2 Study of GSK’s Belantamab Mafodotin is Positive

September 4, 2019

Impact: High

  • GSK has announced that the pivotal phase 2 DREAMM-2 trial (NCT03525678) of belantamab mafodotin has met the primary endpoint of ORR.
  • 196 relapsed multiple myeloma patients who were refractory to an immunomodulatory drug, a PI and an anti-CD38 antibody were enrolled.
  • Safety and tolerability are reportedly consistent with what was observed in the DREAMM-1 trial.
  • Data will be submitted for presentation at an upcoming scientific meeting and be used to support regulatory filings later this year.

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Amgen Wins U.S. Patent Case on Enbrel

August 21, 2019

Impact: High

Amgen announced that the U.S. District court of New Jersey ruled in favor of Amgen regarding the validity of two patents protecting exclusivity of Enbrel from biosimilars. 

Sandoz immediately announced that it would appeal the ruling.

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Keytruda Monotherapy Approved for 2L+ Esophageal Cancer

August 13, 2019

Impact: High

Get insight from inThought Research experts on the recent approval of Keytruda Monotherapy for 2L+ Esophageal cancer:

  • Merck has announced that FDA has approved Keytruda (pembrolizumab) as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 10), with disease progression after one or more prior lines of systemic therapy.
    • PD-L1 positivity will be determined by an FDA-approved companion diagnostic.
  • The approval is based on data from KEYNOTE-181 and KEYNOTE-180.
  • In KEYNOTE-181, the mOS for PD-L1+ esophageal squamous cell carcinoma (ESCC) patients treated with Keytruda was 10.3 months vs. 6.7 months in the chemotherapy arm (HR=0.64; p not provided).
    • The mPFS was 3.2 months for Keytruda treated patients vs. 2.3 months for the chemotherapy arm (HR=0.66, p not provided).
    • An ORR of 22% (CR rate=5%) was observed in Keytruda treated patients compared with 7% (CR rate=1%) in the chemotherapy arm.

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