Oct 11

REGULATORY

SNAPSHOTS: Copiktra receives FDA approval for CLL and FL, Relief for tazemetostat developers after FDA lifted partial clinical hold, Conference highlights from 19th WCLC

The United States Food and Drug Administration (USFDA) has granted approval to Verastem’s Copiktra (duvelisib), for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL/SLL) and follicular lymphoma (FL). The approval was based on positive results from the Phase III DUO trial and Phase II DYNAMO study wherein duvelisib reduced the risk of disease progression by 60% when compared with ofatumumab. The median progression-free survival of 16.4 months with duvelisib and 9.1 months with ofatumumab was found from the DUO trial. In the Phase II DYNAMO trial, duvelisib showed an ORR of 42% in patients with FL.

Additionally, it was a good news for the developers of tazemetostat as the partial clinical hold was lifted by the USFDA. The hold was initially placed after a safety update was provided in a patient. As per the update, the patient attained partial response in approximately 15 months. Following the diagnosis of the secondary malignancy, the patient discontinued treatment with tazemetostat and received therapy for T-cell lymphoma.

Moreover, the key takeaways from the 19th World Conference on Lung Cancer held in Toronto, Canada included positive results from the Phase III PACIFIC trial of durvalumab in NSCLC, Phase II data poziotinib, and interim findings of phase III IMpower132 and IMpower133 trial in NSCLC and SCLC.

 

Lilly wins approval for migraine drug Emgality; plans selling it at rivals’ price to grab market

The USFDA approved Eli Lilly’s Emgality, chemically known as galcanezumab indicated for migraine, marking company’s third approval from a promising new class of treatments. The company intends to sell the product at a list price of USD 6,900 a year, or USD 575 month which is identical to the prices of its rivals including Aimovig from Amgen Inc and Novartis AG, and Ajovy from Teva Pharmaceutical. Lilly has further stated that it plans to launch a similar program which would ensure commercially insured patients to receive up to twelve months of Emgality at zero cost to the patient.

Also, the company is in late-stage discussions with some of the top U.S. health insurance companies and pharma benefit managers regarding negotiations around rebates and discounts off the list price. Potential value-based payment models are also part of the discussion which would allow employers and insurers to reclaim some money if the drug is not effective for a patient.

 

 

 

Eisai’s Fycompa gets expanded approval by USFDA to cover Partial-Onset Seizures in Pediatric Patients with Epilepsy

Eisai’s Fycompa which is an orally administered, first-in-class antiepileptic drug (AED) having high selectivity for AMPA receptor reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.

The product was granted approval by the United States Food and Drug Administration (USFDA) to cover partial-onset seizures in pediatric patients with epilepsy 4 years of age and older on October 1, 2019. The approval was based on the interim results of a Phase III as well as Phase II clinical study evaluating pediatric patients with epilepsy. Both the studies confirmed that the safety and efficacy of the product in adult and pediatric patients were similar.

The product is currently approved in more than 55 countries as adjunctive partial-onset seizures treatment in patients with epilepsy 12 years of age or older. It is additionally approved in more than 50 countries for PGTC seizures in patients with epilepsy 12 years of age and older.

 

Astellas’ Roxadustat files in Japan for Anemia Associated with Chronic Kidney Disease in Patients on Dialysis

Astellas Pharma and its partner FibroGen filed a New Drug Application (NDA) seeking approval of roxadustat in Japan for the treatment of anemia associated with chronic kidney disease in patients undergoing dialysis. The positive results obtained in Phase III studies evaluating CKD patients on dialysis support this NDA submission.

The company believes that the product has the potential to become a new therapeutic option for patients.

 

Janssen’s Esketamine Nasal Spray filed for treatment-resistant depression

Janssen, a part of Johnson & Johnson filed a New Drug Application (NDA) to the USFDA to advance its esketamine nasal spray for treatment-resistant depression in adult patients. The product is rapidly acting antidepressant that works differently than currently available therapies for major depressive disorder. Esketamine has also been granted Breakthrough Therapy designation for both treatment resistant depression and major depressive disorder.

NDA filing is supported by the encouraging positive outcomes of 5 Phase III pivotal trials amongst which one was a withdrawal maintenance of effect study, three were short-term and one was a long-term study.

As part of the developmental plan, the product is currently undergoing Phase III clinical studies for the second indication. Moreover, the company plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) later in 2018 for its primary indication, treatment resistant depression.

 

 

 

FDA Okays Zydus Cadila’s Exemestane tablets for treatment of breast cancer; company plans entering USD 68 million market

On October 5, 2018, the United States Food and Drug Administration (USFDA) granted approval to Zydus Cadila’s Exemestane tablets for the treatment of women with breast cancer. As per the said plans, the company will manufacture the drug at the company’s manufacturing facility in Ahmedabad. Moreover, the breast cancer drug is estimated to capture about USD 68.6 million of the total market.

 

FDA nods Roche’s Hemlibra for haemophilia A without factor VIII inhibitors

The USFDA approved Roche’s Hemlibra for hemophilia A without factor VIII inhibitors. The drug is intended to work as a prophylactic product and cause reduction in the frequency of bleeding episodes in patients. Hemlibra has an upper hand over other hemophilia approved products as it is the only prophylactic treatment for people with hemophilia with and without factor VIII inhibitors that can be administered subcutaneously and at multiple dosing options.

The marketing authorization of Hemlibra is based on the positive outcomes from the Phase III HAVEN 3 and HAVEN 4 studies. As per the results of the two trials, Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds in comparison to no prophylaxis (primary endpoint) and across all other bleed-related endpoints in the HAVEN 3 study, and showed a clinically meaningful control of bleeding in the HAVEN 4 study.

Hemlibra was initially approved by the FDA in November last year for hemophilia A treatment with factor VIII inhibitors in adults and pediatric patients. The Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA) and submissions to other regulatory authorities around the world are ongoing.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.