Zydus receives USFDA’a approval for marketing its epilepsy and menopause drugs.
Pharma news- On 2 December 2022, Zydus received the USFDA’s[1] green signal to market Estradiol Transdermal System, USP[2] in the U.S. market. The approved formulations are 0.025mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day estradiol transdermal systems.
This drug is indicated for treating moderate to severe symptoms of menopause, such as feelings of warmth in the face, hot flashes, and vaginal dryness in women. The company revealed that the drug would be formulated in the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.
The USFDA also granted final permission to Zydus LifeSciences Ltd to market Topiramate extended–release capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. Per the IQVIA[3] statistics, Topiramate extended–release capsules had yearly sales of USD 68.2 million in the United States.
The drug is indicated for the prevention and control of seizures in people with epilepsy and for the prevention of migraines. The drug will be manufactured in the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
It has been noted that Zydus has filed over 431 ANDAs[4] since the beginning of the filing procedure in 2003 – 04 and now has around 336 approvals.
Abbreviation: 1. United States Food and Drug Administration
2. United States Pharmacopoeia
3. Formerly known as Quintiles and IMS Health, Inc.
4. Abbreviated New Drug Application
Also read
- JCR Pharma plans to expand production
- Pharma News – 2 July 2020
- What is the role of USFDA in protecting health?
- Pharma News Update – 20 August 2020
- Pfizer COVID – 19 vaccine in India Update
Drug makers Sun Pharma and Dr.Reddy’s recall products in the U.S. market
Dr.Reddy’s has initiated a Class III recall of over 48,000 cartons of a drug from the U.S. market. This drug was used for treating sneezing and runny or stuffy nose. Around 25,176 cartons of 30 – count tablets and 22,968 cartons of 20 – count tablets were recalled simultaneously on 21 November 2022.
Per the USFDA[1], New – Jersey-based Dr.Reddy’s move to recall these products was attributed to the “failed stability specifications.”
The enforcement report by the USFDA also revealed that Sun Pharma recalled around 14,064 cartons of its product from the U.S. market. The recalled drug was employed for treating erosive esophagitis or heartburn caused by GERD[2].
This affected batch was manufactured in the company’s Mohali plant and was under the radar due to “discoloration.”Sun Pharma began this nationwide voluntary Class II recall in the U.S. on 25 July 2022. (Pharma news)
Abbreviations:
- 1. United States Food and Drug Administration.
- 2. Gastroesophageal Reflux Disease.
Mei Pharma and Kyowa Kirin jointly announce the discontinuation of the development of Zanselisib outside of Japan.
Pharma news- On 5 December 2022, Mei Pharma and Kyowa Kirin announced their decision to discontinue the development of Zanselisib outside of Japan. This latest move by the pharma companies was based on the regulatory guidance from the US FDA [1] and is not related to the clinical data generated by the drug.
In March 2022, the FDA asked the companies to conduct a randomized trial in patients with indolent non-Hodgkin lymphoma. This suggestion was put forth to counter the challenge of risk/benefit of PI3K[2] inhibitors which were not addressed in the phase 2 TIDAL trial. Patients with relapsed or refractory follicular lymphoma were recruited for the single-arm TIDAL trial.
The FDA also emphasized that the companies continue the ongoing randomized Phase 3 COASTAL trials in patients with relapsed or refractory follicular or marginal zone lymphomas.
In a follow–up meeting in late November 2022, the FDA provided further guidance on the design and statistical analysis for the COASTAL trial. Post this, the companies affirmed that a clinical trial consistent with the expectations of the FDA would not be feasible to complete within the time. The companies further stressed the difficulty in procuring additional investments required to modify the COASTAL trial.
Kyowa Kirin is reportedly continuing the ongoing Phase 2 MIRAGE trial of zanselisib in Japan. This trial recruited Japanese patients with relapsed or refractory indolent B – cell non – Hodgkin lymphomas. Kyowa added that the companies plan to officially submit the data generated in the MIRAGE and TIDAL trials for authorization in Japan.
In line with the current announcement, both companies plan to immediately start winding – down the ongoing clinical trials outside of Japan. Based on the achievement of certain regulatory and commercial milestones in Japan, Mei can get additional payments from Kyowa under the current agreement. In such cases, Mei is also entitled to earn royalties on the sales of zanselisib in Japan.
Abbreviation:
- 1. United States Food and Drug Administration.
- 2. Phosphoinositide 3 – kinase
MFDS approves phase I clinical trial plan of CHA Vaccine’s shingles vaccine
CHA Vaccine Institute’s Phase I clinical trial plant for developing CVI – VZV – 001, a shingles vaccine candidate, received the MFDS’s[1] approval on 6 December 2022. This vaccine is a recombinant protein that can potentially suppress postherpetic neuralgia (PHN) effects.
The institute plans to recruit 24 healthy adults aged 50 to 65 to evaluate the dose–specific safety and tolerability of CVI – VZV – 001. The institute will also study the maximum and recommended dose and the immunogenicity of phase 2 clinical trials.
CVI – VZV – 001, developed by CHA Vaccine Institute, is a recombinant protein vaccine based on an immune-enhancing platform, Lipo–pam. This platform induces a cellular immune response that suppresses the shingles virus activation at the latent infection state (Pharma news).
A company official further revealed that the immunostimulant applied to this vaccine is widely used in chronic hepatitis B treatment vaccines. This adjunct is reportedly progressing through phase 2b trials in Korea without any incidence of severe pain.
Abbreviation:
1. Ministry of Food and Drug Safety.
CMC Pharmaceuticals awarded an SBIR grant from the U.S. Defense Department
The U.S. Defense Department’s (DoD) JPEO-CBRND[1], in collaboration with Defense Threat Reduction Agent, has awarded a sequential Phase II SBIR[2] grant to CMC Pharma. This award funds the continued development of a promising medical countermeasure (MCM) for nerve agents. CMC Pharma has especially received this grant for devising MCMs against nerve agents containing a stable, fixed-dose combination of formulation of atropine and scopolamine.
CMC Pharma has revealed its plant to perform proof–of–concept nonclinical studies and chemistry, manufacturing, and control activities to ready the MCM for pre-IND[3] discussions with the FDA[4]. In addition, the company also plans to identify an appropriate cGMP drug product manufacturing site for the material needed for IND – enabling and clinical studies.
The program funded by DoD aims to develop MCM to protect the Service Members against nerve agents, especially organophosphate nerve poisoning. A combination of atropine and scopolamine is proven to increase the therapeutic efficacy of the current treatment regimen. Moreover, this synergistic duo minimizes the logistical burden of carrying and administering a multi-drug MCM regimen.
CMC Pharma envisions executing future studies to support the FDA approval of the drug product. Besides this, the company hopes to secure the appropriate supply chain to provide the drug to the service members of DoD. The pharma major also emphasized the issuance of this drug to the members stationed in the areas of Nerve Agent Threat Potential and to the Strategic National Stockpile.
Abbreviation:
- 1. Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense.
- 2. Small Business Innovation Research.
- 3. Investigational New Drug.
- 4. U.S. Food and Drug Administration.
Delta – Fly Pharma’s DFP – 10917 granted Orphan Drug Designation by the USFDA
On 7 December 2022, the USFDA[1] granted the Orphan Drug Designation (ODD) to DFP – 10917 for the treatment of Acute Myeloid Leukemia (AML). This drug is a leading pipeline of Delta–Fly Pharma.
Phase 3 clinical studies of this drug are underway at the MD Anderson Cancer Center in Texas and other major sites of Haematologic Cancer Treatment in the U.S. The pharma company revealed that it plans to complete the patients’ enrolment plan for this study very soon.
The ODD status entitles Delta–Fly Pharma to seven extra years of marketing exclusivity and additional benefits like an R&D[2] rebate by getting approval.
Abbreviation:
- 1. United States Food and Drug Administration.
- 2. Research & Development.
Pingback: Aculys Pharma and Four H Research Collaboration > PharmaCampus
Pingback: OAI notice for Torrent Pharma Indrad facility > PharmaCampus