Allergan, BMS, 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 Allergan, Bristol-Myers Squibb, GlaxoSmithKline, and Teva.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday October 19, 2016 to Tuesday October 25, 2016.
FDA Committee Recommends Approval of Allergan’s Bladder Drug
Allergan and its partner, Serenity Pharmaceuticals, headquartered in Milford, Pennsylvania, have received a recommendation for approval from an advisory committee at the US Food and Drug Administration (FDA) for SER120 (desmopressin nasal spray), a low-dose, nasally administered investigational drug developed for treating nocturia, an urological disorder.
The FDA is not bound by the committee’s recommendation, but takes its advice into consideration when reviewing investigational medicines. The FDA is expected to take action on the SER120 new drug application in the fourth quarter of 2016.
SER120 is a low-dose, nasally administered investigational drug being evaluated as a treatment for nocturia in adults who awaken two or more times per night to empty the bladder. It is being developed by Serenity, which has had a license and commercialization agreement with Allergan since 2010 for the development and commercialization of SER120.
FDA to Give Priority Review to BMS for Expanded Cancer Drug Indication
Bristol-Myers Squibb’s supplemental biologics license application (sBLA) seeking to expand the use of Opdivo (nivolumab) to patients with locally advanced unresectable or metastatic urothelial carcinoma has been accepted and given priority review by the US Food and Drug Administration (FDA). The FDA action date on the sBLA is March 2, 2017.
BMS’ Opdivo is a human antibody designed to alleviate immune suppression and is approved for various cancers. It is indicated for the treatment of patients with non-small cell lung cancer 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
GSK Submits US Filing for Shingles Vaccine
GlaxoSmithKline (GSK) has submitted a biologics license application for its candidate shingles vaccine, Shingrix to the US Food and Drug Administration, seeking approval for the prevention of herpes zoster (shingles) in people aged 50 years or over.
The candidate vaccine is a non-live, recombinant vaccine to help prevent shingles and its complications. The Phase III clinical trial program showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia, a form of chronic pain associated with shingles. Regulatory approval is being sought for the vaccine to be given intramuscularly in two doses, with a two to six month interval between doses.
Regulatory submissions in the European Union and Canada are on track for 2016 and planned for Japan in 2017.
FDA Accepts Teva’s Resubmitted Application for Huntington’s Disease Drug
The US Food and Drug Administration (FDA) has accepted the resubmission of Teva Pharmaceutical Industries’ new drug application (NDA) for deutetrabenazine for treating chorea associated with Huntington disease (HD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 3, 2017.
Deutetrabenazine was granted orphan drug designation for the treatment of HD by the FDA in November 2014. The resubmission of the NDA follows the receipt of a Complete Response Letter from the FDA in May 2016.
Source: Teva Pharmaceutical Industries