Granules India Receives US FDA Approval for Glycopyrrolate Oral Solution

Overview

Granules India announced that the US Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for glycopyrrolate oral solution 1mg/5mL filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company.
 
It is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa oral solution, 1 mg/5 mL of Merz Pharmaceuticals, LLC.

 Glycopyrrolate Oral Solution

Glycopyrrolate oral solution is an anticholinergic medication indicated for paediatric patients aged three to 16 years who have neurological conditions associated with problem drooling.

 Words from Granules India Limited

As we strengthen Granules’ footprint in the US market, this approval highlights our robust quality systems, ensuring compliance with the highest regulatory standards,"" said Dr Krishna Prasad Chigurupati, chairman and managing director, Granules India Limited.

 About Granules India Limited

Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and a commitment to operational excellence, quality, and customer service.

AbbVie receives European Commission’s conditional marketing authorization for epcoritamab

AbbVie receives European Commission’s conditional marketing authorization for epcoritamab to treat adults with relapsed/refractory follicular lymphoma

Overview

AbbVie announced that the European Commission (EC) has granted conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy.

Tepkinly:  T-cell Bispecific Antibody

Tepkinly is the first and only subcutaneous T-cell engaging bispecific antibody approved to treat both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) in the European Union (EU), as well as the European Economic Area (EEA) countries (Iceland, Liechtenstein, Norway) and Northern Ireland.

Words from AbbVie

• The European approval of Tepkinly for the treatment of follicular lymphoma after two or more prior treatments is yet another step forward in our aspiration to develop Tepkinly as a potential core therapy across multiple B-cell malignancies. First approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, its expansion into follicular lymphoma underscores its utility as a hematological cancer treatment,” said Mariana Cota Stirner, vice president, therapeutic area head for hematology, AbbVie. 
• Together with our partner, Genmab, we are thrilled with today’s approval which advances our commitment to elevating care for people living with cancer.”

About Follicular lymphoma

• Follicular lymphoma is typically a slow-growing form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30% of all cases. 
• FL is considered incurable, and there is no standard of care treatment for third-line or later FL.
• Patients often relapse and with each relapse, the remission and time to next treatment is shorter. 
• Over time, transformation to DLBCL, an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients.

From the Follicular Lymphoma Foundation

• The approval of epcoritamab by the European Commission is a promising update for the lymphoma community,” said Kate Rogers, CEO of the Follicular Lymphoma Foundation. 
• Given that relapsed or refractory follicular lymphoma is a very challenging form of cancer to treat, especially in later lines of therapy, it is critical that patients and physicians have additional options when it comes to treating this type of cancer.”

Behind Marketing Authorization

• The conditional marketing authorization is supported by data from phase 1/2 EPCORE NHL-1 clinical trial: an open-label, multi-cohort, multicenter, single-arm trial that evaluated Tepkinly as monotherapy in patients with R/R FL after two or more lines of prior systemic therapy. 
• The study included patients who were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent (70% having double refractory disease), patients who were refractory to last prior treatment (82%), and patients whose disease progressed within two years of initiating any first systemic therapy (52%). 
• The results published in the Lancet Haematology showed that patients treated with Tepkinly (n=128) had an overall response rate of 83% and a complete response (CR) rate of 63%. 
• At a median follow-up of 16.2 months, the median duration of response was 21.4 months (13.7, NR). Duration of complete response was not reached.

About the Study

• The study included a planned separate optimization cohort, which evaluated 86 patients with the recommended 3-step-up doses for cytokine release syndrome (CRS) mitigation. 
• Hospitalization was not mandatory in the cycle 1 optimization cohort. 
• With the optimized regimen, 40% of patients experienced Grade 1 CRS and 9% experienced Grade 2 (no Grade 3 or higher CRS were reported). 
• No immune effector cell-associated neurotoxicity syndrome (ICANS) cases were reported in this cohort.

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