Pfizer, J&J, and Allergan Lead Pipeline News

A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Johnson & Johnson, Pfizer, and Allergan.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, September 20, 2017 to Tuesday, September 26, 2017.

Janssen Receives CRL from FDA for Arthritis Drug
Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its biologics license application (BLA) for sirukumab, a drug to treat rheumatoid arthritis (RA). The CRL is requesting additional clinical data to further evaluate the safety of sirukumab in treating moderately to severely active RA.

The company said that it is reviewing the details of the CRL and plans to have a follow-up discussion with the FDA to gain a full understanding of the FDA requirements for US approval.

In August 2017, the FDA’s Arthritis Advisory Committee did not recommend approval of sirukumab for RA over issues of the safety profile.

Sirukumab is a fully human monoclonal IgG1 kappa antibody that selectively blocks circulating IL-6, a naturally occurring protein that is believed to play a role in autoimmune conditions such as RA, according to Janssen Biotech. Janssen Biotech submitted the BLA in September 2016.

Sirukumab is currently being evaluated by health authorities in US, Europe, and Japan as a subcutaneous therapy for treating adult patients with moderately to severely active RA.

Janssen currently holds exclusive rights to commercialize sirukumab in Europe, the Middle East, Africa and Asia Pacific, and will regain exclusive, worldwide commercial rights in November 2017 following GlaxoSmithKline’s recent decision to terminate its rights under a 2011 agreement that had given it co-development rights and the right to commercialize sirukumab in North, Central,and South America.

Source: Johnson & Johnson

FDA Advisory Committee Recommends New Use for Pfizer’s Cancer Drug
The US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted against the benefit-risk profile for Pfizer’s Sutent (sunitinib) as an adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).

The ODAC discussions were based on the supplemental new drug application (sNDA) currently under review by the FDA. The FDA decision on whether or not to approve the sNDA is anticipated by January 2018.

Sutent was first approved in the US in 2006 for treating advanced RCC. The drug is approved in 119 countries.

Source: Pfizer

Allergan Receives Refusal to File Letter from FDA for Schizophrenia Drug
Allergan has received a Refusal to File (RTF) letter from the US Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Vraylar (cariprazine) for treating negative symptoms associated with schizophrenia in adult patients.

Vraylar is an oral, once-daily atypical antipsychotic approved in the US for treating schizophrenia and adult patients with manic or mixed episodes associated with Bipolar I Disorder. Cariprazine is also approved in Europe for treating schizophrenia.

Upon its preliminary review, the FDA determined that the sNDA for treating negative symptoms was not sufficiently complete to permit a substantive review. 

The company said it will seek immediate guidance and is in the process of planning a meeting with the FDA to respond to the issues and to seek clarification of what additional information will be required.

Source: Allergan

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