AbbVie, AstraZeneca, BMS, Novo Nordisk, and Teva Lead Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from AbbVie, AstraZeneca, BMS, Novo Nordisk, and Teva.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday October 12, 2016 to Tuesday October 18, 2016.
AbbVie Gets Positive European Opinion on Leukemia Drug
AbbVie has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for Venclyxto (venetoclax) tablets for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor.
The European Commission will review the opinion and make a final decision in late 2016. Venclyxto is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the US and by AbbVie outside of the US. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase III clinical trials for the treatment of relapsed/refractory CLL, along with studies in several other cancers.
In April 2016, the US Food and Drug Administration (FDA) granted accelerated approval of venetoclax tablets for the treatment of patients with CLL with 17p deletion as detected by an FDA-approved test, who have received at least one p(rior therapy. Venetoclax is under evaluation by health authorities in multiple countries and is currently approved in Argentina, Puerto Rico, and Canada.
FDA Grants Fast Track Designation to Astellas for Pain Med
Astellas Pharma and Chromocell Corporation, a life-sciences company based in North Brunswick, New Jersey, have received fast track designation by the US Food and Drug Administration for the drug candidate CC8464/ASP1807, for the management of neuropathic pain associated with idiopathic small fiber neuropathy. In 2015, Astellas and Chromocell entered into a license and collaboration agreement for the development and commercialization of CC8464/ASP1807 for the management of neuropathic pain and other pain indications.
Chromocell submitted the investigation new drug application for CC8464/ASP1807 in July 2016. The compound is an oral, selective, peripherally-restricted inhibitor of NaV1.7, an ion channel involved in pain transmission.
FDA Accepts Re-submission of AstraZeneca’s Hyperkalemia Drug
The US Food and Drug Administration (FDA) has accepted a complete re-submission of a new drug application from AstraZeneca for sodium zirconium cyclosilicate for treating hyperkalemia, by ZS Pharma, a wholly owned subsidiary of AstraZeneca. The FDA has indicated that this is a complete Class 2 response. Interactions with other health authorities in the European Union and Australia are ongoing with decisions expected in the first half of 2017.
Sodium zirconium cyclosilicate is an insoluble, non-absorbed compound with a structure that was designed to preferentially capture potassium ions. Sodium zirconium cyclosilicate is an investigational medicine that is not currently approved for any indication in any market.
EMA Recommends Approval of New Indication for BMS’ Opdivo
Bristol-Myers Squibb has received a recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for Opdivo (nivolumab) in the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
BMS’ Opdivo is a human antibody designed to alleviate immune suppression. It is indicated for the treatment of patients with non-small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. In the US, Opdivo is approved as a single agent for treating BRAF V600 wild-type unresectable or metastatic melanoma and as a single agent for treating BRAF V600 mutation-positive unresectable or metastatic melanoma. It is also approved in combination with Yervoy (ipilimumab) for treating unresectable or metastatic melanoma and for treating advanced renal cell carcinoma that has received prior anti-angiogenic therapy. It is also approved for treating patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.
Opdivo is projected to be a blockbuster drug by some analysts. In 2015, it had global sales of $942 million, and a recent Thomson Reuters analysis projects that 2019 sales will reach nearly $8.9 billion.
Source: Bristol-Myers Squibb
Novo Nordisk Gets Complete Response Letter for Long-Acting Insulin
Novo Nordisk has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) for faster-acting insulin aspart for diabetes management. In the CRL, the FDA requests additional information related to the assay for the immunogenicity and clinical pharmacology data before review of the NDA can be completed. Novo Nordisk is evaluating the content of the CRL and said it will work closely with the FDA to resolve the outstanding issues.
The NDA for faster-acting insulin aspart was submitted to the FDA in December 2015. Faster-acting insulin aspart is currently also under review in the European Union, Switzerland, Canada, Brazil, South Africa and Argentina. Novo Nordisk markets its original insulan aspart under the brand name Novolog, which was approved by the FDA in June 2000 for treating adults and children with diabetes mellitus.
Source: Novo Nordisk
Teva Gets Positive Opinion from EMA to Extend Leukemia Drug Indication…
Teva Pharmaceutical Industries has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an indication extension for Teva’s leukemia drug, Trisenox (arsenic trioxide). The indication extension is for use in newly diagnosed low-to-intermediate risk acute promyelocytic leukemia (APL) in combination with retinoic acid. The CHMP recommendation will now be reviewed by the European Commission (EC), which has authority to approve medicines for use in the 28 countries of the European Union along with Norway, Liechtenstein, and Iceland. A final decision by the EC is expected by the end of this year.
Trisenox in Europe is currently indicated for second-line treatment of patients who have not responded to treatment with retinoids and chemotherapy or when their disease has returned after this type of treatment.
In March 2002, the EC granted approval for the marketing authorization application for Trisenox for treating patients with relapsed or refractory acute APL and characterized by the presence of the t(15;17) translocation and/or the presence of the pro-myelocytic leukemia/retinoic-acid-receptoralpha (PML/(RARα) gene.
Trisenox received marketing authorization by the US Food and Drug Administration in 2000 for induction of remission and consolidation in patients with acute APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Source: Teva Pharmaceutical Industries
…And FDA Halts Teva, Regeneron Clinical Trial for Pain Therapy
The US Food and Drug Administration (FDA) has placed a hold on a Phase IIb clinical study of fasinumab for treating chronic low-back pain and requested an amendment of the study protocol from Teva Pharmaceutical Industries and Regeneron Pharmaceuticals. Fasinumab is an investigational nerve growth factor antibody in clinical development by Teva and Regeneron for osteoarthritis pain and chronic low back pain.
As a result of the FDA decision, Regeneron completed an unplanned interim review of results and has stopped dosing in the study. Based on trial results, Teva and Regeneron plan to design a Phase III study in chronic low-back pain that excludes patients with advanced osteoarthritis. The companies plan to submit a program plan for review with the FDA and other health authorities.
Teva and Regeneron are collaborating on the global development and commercialization of fasinumab. Under a separate agreement with Regeneron, Mitsubishi Tanabe Pharma has exclusive development and commercial rights to fasinumab in Japan, Korea, and nine other Asian countries.
Source: Teva Pharmaceutical Industries