Merck & Co., J&J, Novartis, Teva and Novo Nordisk Lead Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Merck & Co., Johnson & Johnson, Novartis, Celgene, Teva Pharmaceutical Industries, and Novo Nordisk.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, October 18, 2017 to Tuesday, October 31, 2017.

Merck & Co. Has Setback for Additional Use for Cancer Drug Keytruda
Merck & Co. has withdrawn its European application for Keytruda, (pembrolizumab), its immuno-oncology drug, in combination with pemetrexed and carboplatin as a first-line treatment for metastatic nonsquamous non-small cell lung cancer (NSCLC). Keytruda had 2016 global revenues of $1.4 billion.

The application was based on findings from a clinical trial, KEYNOTE-021, Cohort G. Merck & Co. said that these studies showed improvements in overall response rate and progression-free survival for the Keytruda combination regimen compared to chemotherapy alone. The company’s clinical development program includes a number of studies evaluating Keytruda in combination with chemotherapy in the NSCLC setting, according to Merck & Co. The company says it “looks forward to sharing data from these studies with regulatory authorities and the medical community as they become available.”

In the US, Keytruda is approved in combination with pemetrexed and carboplatin as a first-line treatment of patients with metastatic nonsquamous NSCLC. It is also approved as a single agent for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression, as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. It is also approved a single agent for treating metastatic NSCLC whose tumors express PD-L1, as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.

Keytruda is indicated for treating various cancers: unresectable or metastatic melanoma; locally advanced or metastatic urothelial carcinoma, head and neck cancer, classical Hodgkin lymphoma, certain forms of gastric cancer, and microsatellite instability-high cancer.

Source: Merck & Co.


J&J Halts Development of  Drug Candidates for Rheumatoid Arthritis and Leukemia
Johnson & Johnson (J&J) has decided not to pursue global approvals of sirukumab for treating moderately to severely active rheumatoid arthritis (RA) as announced as part of the company’s third-quarter earnings report in October 2017. In addition, its clinical trial for talacotuzumab, an investigational compound being studied in patients with acute myeloid leukemia, has been discontinued.

In September 2017, Janssen Biotech, one of the Janssen Pharmaceutical Companies of J&J, received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its biologics license application for sirukumab. The CRL requested additional clinical data to further evaluate the safety of sirukumab. In August 2017, the FDA’s Arthritis Advisory Committee did not recommend approval of sirukumab for RA over issues of the safety profile.

Source: Johnson & Johnson


Novartis Submits sBLA for Additional Use for CAR-T Therapy Kymriah
Novartis has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for its chimeric antigen receptor (CAR-T) therapy, Kymriah (tisagenlecleucel), for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for autologous stem-cell transplant. If approved, this would be the second indication approved by the FDA for Kymriah.

In August 2017, Kymriah became the first available CAR-T therapy when it received FDA approval for treating patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a treatment that uses a patient’s own T cells to fight cancer.

Source: Novartis


Celgene in Setback for Phase III Drug for Crohn’s Disease
Celgene Corporation has discontinued a Phase III trial (Resolve) in Crohn’s disease (CD) and an extension trial for its drug candidate, GED-0301 (mongersen). 

Celgene decided to stop the trials following an October 2017 recommendation of the Data Monitoring Committee, which assessed overall benefit/risk during a recent interim futility analysis. There were no meaningful safety imbalances identified in the analysis, according to Celgene.

At this time, the Phase III Define trial in CD will not be initiated. Celgene is waiting to review the full dataset from the Phase II trial with GED-0301 in ulcerative colitis to determine next steps.

The investigational oral antisense therapy GED-0301 (mongersen) is an oligonucleotide that decreases Smad7 protein, thereby potentially impacting TGF-β1 signaling, according to information from Celgene. In patients with Crohn’s disease, abnormally high levels of Smad7 interfere with TGF-β1 anti-inflammatory pathways in the gut, leading to increased inflammation, according to information from the company.

GED-0301 is an investigational compound that is not approved for any use in any country.

Source: Celgene Corporation


Teva Submits BLA for Migraine Drug to FDA
Teva Pharmaceutical Industries has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for preventing migraines.

Source: Teva Pharmaceutical Industries


FDA Advisory Committee Recommends Novo Nordisk’s Diabetes Drug Semaglutide
The Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted in support of approving Novo Nordisk’s once-weekly semaglutide to improve glycemic control in adults with Type II diabetes.

The new drug application for once-weekly semaglutide was submitted to the FDA in December 2016. Semaglutide is currently also under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

Source: Novo Nordisk


FDA Grants Novartis’ Melanoma Drug for Breakthrough Therapy Designation
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with Stage III melanoma with a BRAF V600 mutation following complete resection.

The combination use of Tafinlar + Mekinist was previously approved for other cancer indications.The combination use of Tafinlar + Mekinist in patients with unresectable or metastatic melanoma who have a BRAF V600 mutation is approved in the US, European Union (EU) Australia, Canada, and other countries.The combination of Tafinlar + Mekinist is also approved for the treatment of metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation in the US and advanced NSCLC with a BRAF V600 mutation in the EU.

Tafinlar and Mekinist are also indicated in more than 60 countries worldwide, including the US and EU, as single agents to treat patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Tafinlar and Mekinist target different kinases within the serine/threonine kinase family – BRAF and MEK1/2, respectively – in the RAS/RAF/MEK/ERK pathway, which is implicated in NSCLC and melanoma, among other cancers, according to information from Novartis When Tafinlar is used with Mekinist, the combination has been shown to slow tumor growth more than either drug alone, according to the company. The combination of Tafinlar + Mekinist is currently being investigated in an ongoing clinical trial program across a range of tumor types conducted in study centers worldwide.

Source: Novartis


FDA Grants Shire Orphan Drug Designation for Hemophilia A Drug
The US Food and Drug Administration (FDA) has granted orphan drug designation to Shire’s gene therapy candidate, SHP654, an investigational factor VIII (FVIII) gene therapy for treating hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.

Shire received FDA clearance for the IND application it submitted earlier this year to initiate a global multi-center study with SHP654 to evaluate the safety and optimal dose needed to boost factor VIII activity levels and affect hemophilic bleeding. The company anticipates that the SHP654 Phase I/II study will begin by the end of 2017.

Source: Shire

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