India: CDSCO New Drug Approvals: March 2018

Last Updated: 18 April 2018
Article by Singh & Associates

Most Read Contributor in India, December 2018

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. One of the major functions of CDSCO is approval of new drugs in the country. During the month of March 2018, CDSCO has approved the following drugs classifying them as New Drug Approvals1.

Sr. No. Name of the Drug Approved Indication
1. Cadexomer Iodine Bulk & Powder 100 % w/w (contain 0.9 % w/v Iodine) or Cadexomer Iodine Ointment 500 mg (contains 0.9% w/v iodine) For the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetes ulcers infected traumatic and surgical wounds.
2. Dalfampridine Bulk & Film coated extended release tablet 10 mg For treatment to improve walking in patients with Multiple Sclerosis (MS).
3. Ulipristal Acetate 5 mg tablets For the pro-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

A brief about these drugs is discussed below:

1. Cadexomer Iodine Bulk & Powder

Cadexomer iodine is an iodophor that is produced by the reaction of dextrin with epichlorhydrin coupled with ion-exchange groups and iodine. It is a water-soluble modified starch polymer containing 0.9% iodine, calculated on a weight-weight basis, within a helical matrix.

In India, M/s Virchow Biotech Private Limited presented their proposal for grant of license to manufacture and market this product in India. The firm presented the Phase III Clinical trial report titled 'Safety and efficacy of Dexadine (Cadexomer Iodine) in the treatment of chronic wounds' before the CDSCO's Subject Expert Committee on Antibiotics & Antivirals. After detailed deliberation, the committee recommended the manufacturing and marketing of the products (Cadexomer Iodine Ointment & Cadexomer Iodine Powder), as topical preparations for the treatment of chronic exuding wounds2.

2. Dalfampridine Bulk & Film coated extended release tablet 10 mg

Dalfampridine, also known as 4-Aminopyridine, is a potassium channel blocker, used to improve walking ability in adults with multiple sclerosis (MS), who have a walking disability. MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves. The drug was first approved by the United States Food and Drug Administration (USFDA) on January 22, 20103. The European Medicines Agency (EMA) approved Dalfampridine on July 20, 20114.

In India, M/s Sun Pharmaceutical Industries presented its proposal to CDSCO's Subject Expert Committee (SEC) for Neurology and Psychiatry for the grant of permission to manufacture and market Dalfampridine extended release tablets - 10mg, during the committee's meeting on July 19, 2017. The firm had presented the proposal before the committee twice earlier on February 25, 2014 and on March 18, 2016, wherein the committee did not agree for clinical trial waiver.

The firm, this time, presented that the proposed indication - To improve walking in patients with multiple sclerosis falls under the criteria laid down for clinical trial waiver under the category of orphan drugs for rare diseases. The firm also presented that 1 in 2500 prevalence is being considered as orphan drug for rare diseases and as per the information available there are about 2,00,000 MS patients in the country. The firm also presented the data from the BE study conducted in the country and the test product was found to be Bioequivalent with the innovator product. Further, the firm highlighted that the drug is approved in USA, Canada, EU etc. After detailed deliberation the committee recommended for the grant of permission to manufacture and market the drug subject to the condition that the firm should conduct Phase IV clinical trial in the country and accordingly the protocol etc. should be submitted to the office of DCG(I) within 3 months from the date of approval5.

3. Ulipristal Acetate 5 mg tablets

Ulipristal acetate, is a'selective progesterone receptor modulator'. It acts by blocking the receptor of progesterone hormone in the body, which is involved in controlling the growth of the lining of the womb. In some women, progesterone may promote the growth of fibroids, which may cause symptoms such as heavy uterine bleeding (bleeding from the womb during or outside the menstrual period), anaemia (low red blood cell counts, due to bleeding) and abdominal pain (such as pain during menstrual period or pain in the belly area). When progesterone activity is blocked, fibroid cells stop dividing and eventually die, which reduces both the size of the fibroids and the symptoms caused by them.

Ulipristal acetate was first approved by the United States Food and Drug Administration (US-FDA) on August 13, 20106. The European Medicines Agency (EMA) issued marketing authorization for Ulipristal across European Union on February 23, 20127.

In India, M/s Ferring Pharmaceuticals presented their proposal for grant of license for Ulipristal to the CDSCO's Subject Expert Committee (SEC) for Reproduction and Urology. In the committee's meeting, held on October 17, 2017, the firm presented its proposal along with clinical data including global clinical trial data in which India was a participating country. The committee also noted that drug is already approved for marketing in more than 70 countries including UK, Germany, Canada, Australia etc. After detailed deliberations, the committee recommended for grant of permission to import and market the drug Ulipristal acetate tablets 5 mg for the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age8.

Recent Safety Alert for Ulipristal Acetate

On February 09, 2018, the European Medicines Agency (EMA) recommended that Women taking Ulipristal acetate for uterine fibroids should have regular liver tests. The agency also informed that EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks associated with Ulipristal acetate, following reports of serious liver injury, including liver failure leading to transplantation9.

Hence, as a temporary measure, while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Ulipristal acetate for uterine fibroids. All women taking Ulipristal acetate should have a liver function test at least once a month during the treatment. If the test is abnormal (liver enzyme levels are more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient. Liver tests should be repeated 2 to 4 weeks after stopping treatment. The PRAC is also recommending that no new patients should be started on Ulipristal acetate and no patients who have completed a course of treatment should start another one for the time being.

Footnotes

1. http://www.cdsco.nic.in/forms/list.aspx?lid=2034&Id=11

2. http://www.cdsco.nic.in/writereaddata/Recommendation%20Antimicrobial_13_07_2017.pdf

3. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022250s000ltr.pdf

4. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002097/human_med_001432.jsp&mid=WC0b01ac058001d124

5. http://www.cdsco.nic.in/writereaddata/Recommendation%20Neurology_19_07_2017.pdf

6. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022474s000ltr.pdf

7. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002041/human_med_001542.jsp&mid=WC0b01ac058001d124

8. http://cdsco.nic.in/writereaddata/27th%20SEC%20Recommendations%20of%20Reproductive%20&%20Urology.pdf

9. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Esmya/human_referral_prac_000070.jsp&mid=WC0b01ac05805c516f

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