GSK, Otsuka, and Merck & Co. Lead Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from GlaxoSmithKline, Otsuka, and Merck & Co.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, November 8, 2017 to Tuesday, November 15, 2017.

GSK Seeks New Use for Respiratory Drug Nucala
GlaxoSmithKline (GSK) has submitted a supplemental biologics license application to the US Food and Drug Administration (FDA) seeking approval of mepolizumab as an add-on to maintenance treatment for patients who have chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

Mepolizumab, an interleukin-5 (IL-5) antagonist, is not approved anywhere for COPD. Regulatory filings in other countries are planned during the course of 2017 and 2018.

Mepolizumab is approved for use in the US under the brand name Nucala as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is also approved for severe eosinophilic asthma in the European Union, Japan, and other countries.

Source: GlaxoSmithKline


FDA Accepts Otsuka’s NDA for Kidney Disease Drug Tolvaptan
The US Food and Drug Administration (FDA) has accepted Otsuka Pharmaceutical’s resubmission of a new drug application (NDA) for tolvaptan for treating adults with autosomal dominant polycystic kidney disease (ADPKD).

Otsuka’s resubmission is a response to a Complete Response Letter that the FDA issued in August 2013. The FDA considers the resubmission to be filed as of October 24, 2017, with a Prescription Drug User Fee Act action date of April 24, 2018.

Tolvaptan, a selective vasopressin V2-receptor antagonist, is approved for treating adult patients with ADPKD in Japan, the European Union, Canada, South Korea, Switzerland, Hong Kong, and Australia.

Source: Otsuka Pharmaceuticals


Mylan, Theravance Submit NDA to FDA for COPD Drug
Mylan and Theravance Biopharma, a South San Francisco, California-headquartered biopharmaceutical company, have submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for revefenacin, an investigational long-acting muscarinic antagonist as a once-daily, nebulized bronchodilator for treating chronic obstructive pulmonary disease (COPD).

Under its agreement with Mylan, Theravance is leading the US development program for the revefenacin inhalation solution product, with all costs related to the registrational program reimbursed by Mylan up until the approval of the first NDA, after which costs will be shared. Mylan is responsible for ex-US development and commercialization. Theravance is eligible to receive up to $220 million in development and sales milestone payments, as well as a profit-sharing arrangement with Mylan on US sales and double-digit royalties on ex-US sales. Additionally, Theravance Biopharma retains worldwide rights to revefenacin delivered through other dosage forms, such as a metered-dose inhaler or dry-powder inhaler, and the rights to nebulized revefenacin in China.

Source: Theravance Biopharma


EMA Advisory Committee Recommends Merck & Co.’s Prevymis for Stem-Cell Infections
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Merck & Co.’s Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem-cell transplant.

The CHMP positive opinion will be considered by the European Commission. If the CHMP opinion is affirmed, the European Commission will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries of the European Union as well as in European Economic Area members, Iceland, Liechtenstein, and Norway.

Prevymis was approved by the US Food and Drug Administration in November 2017. In the US, Prevymis is indicated for prophylaxis of cytomegalovirus infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem0cell transplant. Merck & Co. also has filed letermovir for regulatory approval in other markets, including Japan, where it is currently under review.

Under an agreement signed in 2012, Merck (through a subsidiary) purchased worldwide rights to develop and commercialize letermovir from AiCuris GmbH & Co.

Source: Merck & Co.


EMA Advisory Committee Recommends AstraZeneca’s Asthma Drug
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of new molecular entity, benralizumab, from AstraZeneca and its global biologics and development arm, MedImmune, as an add-on maintenance treatment for treating asthma.

Specifically, AstraZeneca is seeking approval as an add-on maintenance for treating asthma in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting b-agonists.

Benralizumab binds directly to the IL-5α receptor on an eosinophil and attracts natural killer cells to induce apoptosis (programmed cell death), according to AstraZeneca. If approved, benralizumab will be available as a once every eight-week fixed-dose subcutaneous injection via a prefilled syringe.

The positive opinion from the CHMP will now be reviewed by the European Commission, which has the authority to approve medicines for the 28 European Union member countries plus Iceland, Norway, and Liechtenstein.

Benralizumab is also under regulatory review in the US, Japan, and several other countries, with a US Prescription Drug User Fee Act date for the fourth quarter of 2017 and expected regulatory decisions elsewhere during the first half of 2018.

Source: AstraZeneca


EMA Advisory Committee OKs Pediatric Use for Amgen’s Rare Blood Disease Drug Nplate
The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended to expand the indication for Amgen’s Nplate (romiplostim) to include treating chronic immune (idiopathic) thrombocytopenic purpura (ITP) for patients one year of age and older who are refractory to other treatments (e.g., corticosteroids, immunoglobulins).

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, a centralized marketing authorization will be granted that will be valid in the 28 countries that are members of the European Union. Norway, Iceland, and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.

Nplate is a thrombopoietin (TPO) receptor agonist indicated for treating low blood platelet counts in adults with chronic ITP, who had an insufficient response to other medicines or surgery. Nplate mimics the body’s natural thrombopoietin and is designed to increase platelet counts in patients with chronic ITP, according to Amgen.

In the US, Nplate is indicated for treating thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. In the EU, Nplate is indicated for treating adult chronic ITP patients who are refractory to other treatments (e.g., corticosteroids, immunoglobulins).

Nplate is also approved in Canada, Australia, Russia, Mexico, Switzerland, Lichtenstein, Japan, Argentina, Israel, South Korea, Hong Kong, Chile, Serbia, Kazakhstan, Malaysia, Singapore, Colombia, Kuwait, Taiwan, South Africa, Brazil, Guatemala, Morocco, Ecuador, Macau, Egypt, Lebanon, Peru, and Venezuela. Nplate received orphan designation for chronic ITP in the US (2003), the EU (2005), Switzerland (2005), Japan (2006), Mexico, and South Korea (2010).

Source: Amgen


EMA Advisory Committee Recommends Approval of Shire’s Hemophilia A Drug Adynovi
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Shire’s Adynovi [antihemophilic factor, recombinant, PEGylated], an extended half-life recombinant Factor VIII (rFVIII) treatment, for treating adults and adolescents ages 12 and older living with hemophilia A for on-demand and prophylactic use.

The CHMP’s positive opinion will be reviewed by the European Commission, which has the authority to grant marketing authorization in the European Union.

Adynovi was approved as Adynovate by the US Food and Drug Administration (FDA) in November 2015 and is also approved in Japan, Canada, and Colombia. It is approved as Adynovi in Switzerland.

Source: Shire

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